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The Scottish Medicines Consortium approves Aubagio® (teriflunomide) for use in MS(11/03/14)

New oral treatment can be offered as an alternative to currently available injectable treatment options.

The Scottish Medicines Consortium (SMC) today published its advice that Aubagio® (teriflunomide) 14 mg tablets has been accepted for use by NHS Scotland for the treatment of adults with relapsing remitting multiple sclerosis (RRMS), as an alternative to the currently available treatment options beta interferon or glatiramer acetate. The guidance does not include patients with highly active MS.

The guidance published by the SMC today represents an important step in improving the standard of care available to people with MS. "MS is a real concern in Scotland as it is a debilitating disease which has a high prevalence. This is good news for people with MS in Scotland and a significant milestone in improving the care of MS patients here," said Dr. Belinda Weller, Consultant Neurologist, Western General Hospital, Edinburgh.

Scotland has among the highest prevalence of MS in the world, with around 10,000 people living with MS in the country. Eighty-five percent of people with MS are initially diagnosed with RRMS and people with this type of MS experience approximately one or two relapses per year. Around half of all relapses may leave people with lingering problems and disability may accumulate over time.

Aubagio is the first medicine in Genzyme's pipeline of MS therapies to receive final SMC guidance and become available to patients in Scotland. "This is a very exciting time and the launch of Aubagio represents an important milestone for Genzyme as we provide new options to the MS community. Our commitment to improving the lives of people with MS goes beyond advancing treatment options, and we have a patient support programme underway to further support patients with adherence," said Brendan Martin, General Manager for Genzyme UK and Ireland.

Source: Genzyme (11/03/14)

MS drug Aubagio wins final approval from NICE(22/01/14)

Sanofi’s multiple sclerosis drug Aubagio won final approval from the U.K.’s health-cost agency, allowing access to a market in which it will compete with Novartis AG’s Gilenya.

The National Institute for Health and Care Excellence, or NICE, recommended Aubagio, also known as teriflunomide, as a treatment option for adults with relapsing-remitting multiple sclerosis, the most common form of the disease, it said in a statement today. The decision confirms a preliminary ruling made last month in which NICE recommended the drug after Paris-based Sanofi agreed to a price cut.

The drug is the second oral MS treatment to win NICE’s backing in the U.K., after Basel, Switzerland-based Novartis’s Gilenya was approved in April 2012. Aubagio is the only oral MS drug to demonstrate an ability to slow the progression of disability in two trials, William Sibold, the head of MS at Sanofi’s Genzyme unit, said in a telephone interview.

“That consistent efficacy is something that resonates very well with the community,” Sibold said.

Aubagio has “blockbuster potential,” Sibold said, without providing a specific sales forecast. The drug may reach sales of 647 million euros ($876 million) in 2018, according to the average of eight analyst estimates compiled by Bloomberg.

Sanofi plans to target the 80 percent of MS patients who use injectable treatments, he said.

The decision means Britain’s National Health Service is obliged to begin paying for the drug within three months, NICE said. Aubagio will come with a list price of £1,037.84 ($1,709) per 28-tablet pack, NICE said, without disclosing the level of the discount.

Source: Bloomberg ©2014 Bloomberg L.P (22/01/14)

Teriflunomide in multiple sclerosis: Added benefit not proven(08/01/14)

Teriflunomide (trade name: Aubagio) has been approved in Germany since August 2013 for adults with relapsing remitting multiple sclerosis. In an early benefit assessment pursuant to the Act on the Reform of the Market for Medicinal Products (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) examined whether this new drug offers an added benefit over the appropriate comparator therapy specified by the Federal Joint Committee (G-BA).

This is not the case, however: Although certain side effects occur less frequently under teriflunomide than under beta interferon 1a, others are more frequent. Overall, IQWiG does not regard an added benefit as proven.

Drug manufacturer limited itself to a certain beta interferon preparation
Multiple sclerosis (MS) is a chronic, incurable, inflammatory disease of the central nervous system, which often has a relapsing course. If there is a remission of all or most symptoms after a relapse, this type of MS is called relapsing-remitting (RRMS).

The Federal Joint Committee (G-BA) specified beta interferons (1a or 1b) or glatiramer acetate as appropriate comparator therapy. The drug manufacturer chose beta interferon 1a as comparator therapy, but limited itself to one certain preparation from this drug group (Rebif). This did not influence the result of the assessment, however. Teriflunomide is taken as a tablet, whereas beta interferon 1a has to be injected.

Only data from an approval study were used
In its dossier, the manufacturer presented results from an approval study (TENERE), which directly compared teriflunomide with Rebif. In this study, patients were treated for 48 to 115 weeks. The study was unblinded, i.e. both patients and doctors knew which drug was administered.

In addition, the manufacturer used an indirect comparison based on three studies, all of which tested teriflunomide or Rebif against placebo. The placebo was used as what is known as the "common comparator". The manufacturer then combined the results of this indirect comparison with the results from TENERE. However, the indirect comparison was unsuitable to support the results from the direct comparison (TENERE). IQWiG therefore only included the data on the direct comparison in the assessment.

No relevant differences in morbidity and quality of life
No conclusions can be drawn on mortality because no patients died during the study. The study was not long enough and did not have enough participants anyway to be able to reveal any differences in mortality.

Regarding disability progression and relapses such as vision disorders, there were no statistically significant differences between the teriflunomide and the interferon group. No statistically significant difference was observed for the outcome "health-related quality of life", either.

Opposing results for side effects
There were also no important differences found with regards to serious adverse events and the outcome "treatment discontinuation due to side effects". The picture is more complex for non-severe or non-serious side effects, however: Flu-like symptoms were less frequent under teriflunomide than under beta interferon 1a. This was also the case for reactions at the injection site, but this side effect cannot occur with a tablet (teriflunomide). In contrast, diarrhoea and hair loss (alopecia) were more frequent in the teriflunomide group.

Reliability of conclusions is limited
Overall, regarding side effects, IQWiG sees a hint of a positive and a negative effect, in each case with a considerable extent. IQWiG regards the reliability of the conclusions of the study to be limited, so that it sees hints, but no indications. One of the reasons is that the study was unblinded.

Balancing the positive and negative effects regarding side effects, the Institute does not regard an added benefit of teriflunomide in comparison with beta interferon 1a as proven.

G-BA decides on the extent of added benefit
The dossier assessment is part of the overall procedure for early benefit assessments supervised by the G-BA. After publication of the manufacturer's dossier and IQWiG's assessment, the G-BA conducts a commenting procedure, which may provide further information and result in a change to the benefit assessment. The G?BA then decides on the extent of the added benefit, thus completing the early benefit assessment.

An overview of the results of IQWiG's benefit assessment is given by a German-language executive summary. In addition, the website gesundheitsinformation.de, published by IQWiG, provides easily understandable and brief German-language information on teriflunomide.

The G-BA website contains both general English-language information on benefit assessment pursuant to §35a Social Code Book (SGB) V and specific German-language information on the assessment of teriflunomide.

Source: PhysOrg © Phys.org™ 2003-2014 (08/01/14)

NICE recommends new oral MS drug Aubagio(06/12/13)

NICE has recommended that the national health service use Sanofi's new multiple sclerosis pill Aubagio, which will be supplied at a discount.

The National Institute for Health and Clinical Excellence (NICE) - the body that decides if drugs should be paid for - said on Friday its final draft guidance recommended Aubagio, or teriflunomide, for adults with relapsing-remitting multiple sclerosis.

The drug's list price is 13,529 pounds per patient a year but the size of the discount has not been disclosed.

On Thursday, NICE said it needed more information before deciding if a separate Sanofi drug for the disease, Lemtrada, was worth using.

Source: Reuters Copywrite Thomson Reuters 2013 (06/12/13)

Oral MS treatment Aubagio® approved for relapsing remitting multiple sclerosis in Canada(20/11/13)

Genzyme, a Sanofi company, announced today that Health Canada has approved Aubagio® (teriflunomide) 14 mg as monotherapy for the treatment of patients with relapsing remitting multiple sclerosis (RRMS) to reduce the frequency of clinical exacerbations and to delay the accumulation of physical disability.

"There are many patients who simply cannot tolerate injections and have had no simple, effective, once daily oral medication until now," said Dr. Mark Freedman, Director, Multiple Sclerosis Research Unit and Professor of Neurology and Senior Scientist at the University of Ottawa and Ottawa Hospital Research Institute. "As a new oral treatment option, Aubagio is an important advancement for the MS community and may help improve quality of life for people living with this debilitating disease."

The Health Canada approval was based on efficacy data from two Phase III clinical trials - TEMSO (TEriflunomide Multiple Sclerosis Oral) and TOWER (Teriflunomide Oral in people With relapsing remitting multiplE scleRosis). In the TEMSO trial, Aubagio 14 mg significantly reduced the annualized relapse rate (p=0.0005) and the time to disability progression (p=0.0279) at two years versus placebo in patients with RRMS. In the TOWER trial, Aubagio 14 mg significantly reduced the annualized relapse rate (p=0.0001) and the time to disability progression sustained for 12 weeks (p = 0.0442) was statistically significantly reduced versus placebo in patients with RRMS.

"MS impacts each person differently, which is why increased options are important when it comes to making personal treatment decisions. The more treatment options that are available the more choices Canadians living with MS have to potentially improve their overall quality of life," said Dr. Karen Lee, Vice-President, Research, Multiple Sclerosis Society of Canada. "As we learn more about MS and develop therapies that reduce the frequency and severity of relapses in relapsing-remitting MS, we hope that we'll also uncover treatments for people whose disease is steadily progressing."

New positive data from the TOPIC study of Aubagio was presented at the 29th Congress of the European Committee for Research and Treatment in Multiple Sclerosis (ECTRIMS) in Copenhagen, Denmark. The double-blind, multi-centre trial enrolled 618 patients who had experienced a first acute or sub-acute, well-defined neurological event consistent with demyelination as well as onset of MS symptoms within 90 days of randomization, and MRI scan showing two or more lesions characteristic of MS. The two-year study was designed to assess whether early initiation of Aubagio in patients who experienced their first neurological symptoms suggestive of MS could prevent or delay a second clinical attack.

The TOPIC study found Aubagio 14 mg significantly reduced the risk of a new clinical relapse over the two-year study period. There was a 35 per cent reduction among patients who received AUBAGIO 14 mg compared to placebo (p=0.0374).

"We are very excited that Aubagio will be available for Canadians living with RRMS," said Peter Brenders, General Manager, Genzyme Canada. "Health Canada's approval of our first MS therapy represents an important milestone for us, and we are proud of our commitment to long-term leadership and partnership with the MS community."

As part of its commitment to MS patients, Genzyme has developed the MS One to One™ program. MS One to One will offer comprehensive support services, including: reimbursement navigation and other financial assistance, patient education and compliance services, medication delivery, and facilitation of the accelerated elimination procedure. Staffed by dedicated MS nurses and highly trained representatives, MS One to One can provide support for individuals living with MS, their health care providers, family and loved ones. Please consult your healthcare provider for more information.

In MS clinical studies with Aubagio, the incidence of serious adverse events were similar among Aubagio and placebo-treated patients. The most common adverse events associated with Aubagio in MS patients included alopecia, diarrhea, increased ALT levels, headache and nausea.

The Aubagio label includes a boxed warning citing the risk of hepatotoxicity and teratogenicity (based on animal data).

The labeling for Aubagio was also informed by the estimated 2.1 million years of patient exposure globally since the launch of leflunomide, which is indicated in the US for the treatment of rheumatoid arthritis. Teriflunomide is the principal active metabolite of leflunomide. Severe liver injury including fatal liver failure has been reported in patients treated with leflunomide.

Aubagio is also approved in the United States, Europe, Australia, Argentina, Chile, South Korea and Mexico for the treatment of relapsing forms of MS. Marketing applications for Aubagio are also under review by additional regulatory authorities globally.

Source: Genzyme (20/11/13)

ECTRIMS - Aubagio(R) significantly reduced risk of new clinical relapse or MRI lesion in MS study(03/10/13)

Genzyme, a Sanofi company , announced positive new data from the TOPIC study of its once-daily, oral Aubagio(R) (teriflunomide). These new data, presented today at the 29th Congress of the European Committee for Research and Treatment in Multiple Sclerosis (ECTRIMS), include the following:

-- Aubagio 14 mg significantly reduced the risk of a new clinical relapse or MRI lesion over the two-year study period. There was a 35 percent reduction among patients who received Aubagio 14 mg compared to placebo (p=0.0003).

-- As measured by MRI over the two-year study period, there was a 5 percent increase in total lesion volume among patients treated with Aubagio 14 mg compared to a 28 percent increase among patients treated with placebo (p=0.0374). In addition, there was a 59 percent reduction in gadolinium-enhancing T1 lesions among patients treated with Aubagio 14 mg compared to placebo (p=0.0008).

Similar results were observed for the 7 mg dose, though the effects did not achieve statistical significance on some endpoints.

The TOPIC trial was designed to assess whether early initiation of Aubagio in patients who experienced their first neurological symptoms suggestive of MS could prevent or delay a second clinical attack, i.e., conversion to clinically definite multiple sclerosis (CDMS).

As previously announced, patients receiving Aubagio 14 mg and 7 mg in the TOPIC trial were significantly less likely than placebo to develop CDMS, the primary endpoint. Compared to placebo, Aubagio 14 mg reduced the risk of conversion to CDMS by 43 percent.

"The findings presented today are encouraging, as they are in line with the body of evidence supporting the value in treating MS early," said Dr. Aaron E. Miller, Medical Director, The Corinne Goldsmith Dickinson Center for Multiple Sclerosis, Mount Sinai Medical Center. "These results demonstrate Aubagio's consistent efficacy and safety across a spectrum of MS patients."

The average duration of Aubagio exposure in TOPIC was approximately 16 months. Adverse events observed in the trial were consistent with previous clinical trials with Aubagio in MS. The most common types of adverse events reported more frequently in the Aubagio arms were ALT (Alanine aminotransferase) elevations, headache, hair thinning, diarrhea, paresthesia and upper respiratory tract infection. There were no deaths reported in either Aubagio group over the course of the study. There was one death due to suicide in the placebo arm. The rate of treatment discontinuation due to adverse events was similar across treatment arms (9.9 percent in placebo arm, compared to 12.1 percent in 7 mg Aubagio arm and 8.3 percent in 14 mg Aubagio arm).

"We are proud to share these results, which underscore Aubagio's potential for treating patients in the earlier stages of MS," said Genzyme President and CEO, David Meeker, M.D. "This study, in addition to the studies that support Aubagio's indication in relapsing remitting MS, reflects our commitment to advancing our understanding of this complex disease."

The trial compared treatment with either 14 mg or 7 mg once-daily, oral Aubagio against placebo. This double-blind, multi-center trial enrolled 618 patients who had experienced a first acute or sub-acute, well-defined neurological event consistent with demyelination, as well as onset of MS symptoms within 90 days of randomization, and MRI scan showing two or more T2 lesions characteristic of MS.

Aubagio is approved in the U.S., EU, Australia, Argentina, Chile, South Korea, and Mexico for the treatment of relapsing forms of MS. Marketing applications for Aubagio are also under review by additional regulatory authorities globally.

Source: MarketWatch © 2013 MarketWatch, Inc (03/10/13)

NICE demands more data for Sanofi's oral MS drug Aubagio(18/09/13)

Sanofi will need to provide more evidence supporting the effectiveness of its oral multiple sclerosis drug Aubagio if it wants the treatment to be recommended for use on the NHS in England and Wales.

The National Institute for Health and Care Excellence (NICE), which assesses the cost-effectiveness of treatments for NHS use, released initial draft guidance which requests several clarifications on the evidence submitted by Sanofi, which is looking to market Aubagio (teriflunomide) as a first-line treatment for relapsing remitting multiple sclerosis (RRMS).

“When reviewing the evidence for teriflunomide, the appraisal committee concluded that there were still questions to be answered about the effectiveness of the drug for adults with RRMS,” said NICE's chief executive Sir Andrew Dillon.

This includes a revision of probabilistic analyses to include the waning of treatment effect and pairwise comparisons to evaluate the cost-effectiveness of plausible NHS practice in RRMS, such as a comparing the use of Aubagio and Rebif-44 to the use of Novartis' Gilenya (fingolimod) and Rebif-44.

Sanofi, which gained rights to the drug as part of its 2011 acquisition of US biotech Genzyme, has until October 8, 2013, to submit this extra information for further review and draft guidance.

Commenting to PMLiVE, a spokesperson from Sanofi/ Genzyme said: "The appraisal consultation document is a long and complex document and we will respond in detail to the questions raised by NICE before the consultation period closes."

The negative draft guidance mirrors a similarly troubled NICE pathway for Novartis' Gilenya, which was approved in 2011 as the first oral treatment available in Europe for the treatment of MS.

Novartis then faced two stages of draft guidance from NICE which deemed Gilenya in its approved RRMS indication was not a cost-effective enough use of NHS resources, despite being provided at an undisclosed discount through a patient access scheme.

NICE later reversed its decision after Novartis provided more data, but only for the use of Gilenya in a sub-group of RRMS patients who have an unchanged or increased relapse rates or ongoing severe relapses compared to the previous year, despite them taking other drugs such as beta interferons.

As with Novartis and Gilenya, Sanofi has a patient access scheme in place for Aubagio to cover part of the drug's cost, which NICE estimates to come to £13,529 per patient per year.

This compares to the £19,196 per patient per year Gilenya is estimated to cost, although it is unclear what the NHS would pay for either medicine considering their respective undisclosed patient access schemes.

Source: PMLive © PMGroup Worldwide Ltd 2013 (18/09/13)

EU grants marketing authorization for teriflunomide for multiple sclerosis(02/09/13)

European Commission Approves Genzyme’s Once-Daily, Oral Multiple Sclerosis Treatment Aubagio® (teriflunomide).

Genzyme, announced that the European Commission has granted marketing authorization for Aubagio®(teriflunomide) 14 mg, a once-daily, oral therapy indicated for the treatment of adult MSers with relapsing remitting multiple sclerosis (RRMS).

“The fact that Aubagio 14 mg has demonstrated a positive effect on disability progression in two phase III clinical studies underscores its importance as a new treatment option for relapsing remitting MS patients," said Professor Ludwig Kappos, MD, Chair of Neurology, University Hospital, Basel, Switzerland. "As a new once-daily, oral treatment option with well-characterized safety and tolerability, Aubagio could be an attractive option for patients dissatisfied with traditional injectable therapies."

The EU approval of Aubagio was based on data from the Phase III TEMSO (TEriflunomide Multiple Sclerosis Oral) and TOWER (Teriflunomide Oral in people With relapsing remitting multiplE scleRosis) trials. In these trials, Aubagio significantly reduced the annualized relapse rate and the time to disability progression at two years versus placebo.

“Aubagio’s efficacy, safety and convenient dosing may provide an attractive treatment option for patients,” said Genzyme CEO and President, David Meeker, M.D. “Today’s approval of Aubagio is another step forward for Genzyme as we work to develop important new treatments that can address the diverse needs of the MS community.”

Multiple sclerosis is estimated to affect more than 2.1 million people globally. There are approximately 630,000 people affected by MS in Europe.

The development of Aubagio reflects more than a decade of work by the Sanofi R&D organization.

Aubagio is approved to treat relapsing MS in the United States, Australia, Argentina, Chile and South Korea, and is under review by additional regulatory agencies.

About Aubagio® (teriflunomide)

Aubagio is an immunomodulator with anti-inflammatory properties. Although the exact mechanism of action for Aubagio is not fully understood, it may involve a reduction in the number of activated lymphocytes in the central nervous system (CNS). Aubagio is supported by one of the largest clinical programs of any MS therapy, with more than 5,000 trial participants in 36 countries. Some patients in extension trials have been treated for up to 10 years.

EU Indication and Usage

Aubagio (teriflunomide) 14 mg is a once-daily, oral therapy indicated in the European Union for the treatment of adult patients with relapsing remitting multiple sclerosis.

U.S. Indication and Usage

Aubagio (teriflunomide) is a once-daily, oral therapy indicated in the U.S. for the treatment of adult patients with relapsing forms of multiple sclerosis. The recommended dose of Aubagio is 7 mg or 14 mg orally once daily.

Important Safety Information About Aubagio

The Aubagio label includes the risk of hepatotoxicity and, teratogenicity (based on animal data).

In MS clinical studies with Aubagio, the incidence of serious adverse events were similar among Aubagio and placebo-treated patients. The most common adverse events associated with Aubagio in MS patients included increased ALT levels, alopecia, diarrhea, influenza, nausea and paresthesia. Teriflunomide is the principal active metabolite of leflunomide, which is indicated in the U.S. and Europe for the treatment of rheumatoid arthritis. Severe liver injury including fatal liver failure has been reported in patients treated with leflunomide.

Leflunomide has an estimated 2.1 million patient years of exposure in rheumatoid arthritis globally since its launch.

Aubagio is contraindicated in patients with severe hepatic impairment, pregnant women and women of childbearing potential who are not using reliable contraception, breast feeding women, patients with immunodeficiency states, patients with significantly impaired bone marrow function or significant anaemia, leucopenia, neutropenia or thrombocytopenia, patients with severe active infection until resolution, patients with severe renal impairment undergoing dialysis and patients with hypoproteinaemia.

Source: Genzyme (02/09/13)

Aubagio does not appear to affect immune response to flu vaccination in MS patients(31/07/13)

Teriflunomide effect on immune response to influenza vaccine in patients with multiple sclerosis.

Abstract

OBJECTIVE: To investigate the effect of teriflunomide on the efficacy and safety of seasonal influenza vaccine.

METHODS: The 2011/2012 seasonal influenza vaccine (containing H1N1, H3N2, and B strains) was administered to patients with relapsing forms of multiple sclerosis (RMS) treated for ≥6 months with teriflunomide 7 mg (n = 41) or 14 mg (n = 41), or interferon-β-1 (IFN-β-1; n = 46). The primary endpoint was the proportion of patients with influenza strain-specific antibody titers ≥40, 28 days postvaccination.

RESULTS: More than 90% of patients achieved postvaccination antibody titers ≥40 for H1N1 and B in all groups. For H3N2, titers ≥40 were achieved in ≥90% of patients in the 7 mg and IFN-β-1 groups, and in 77% of the 14-mg group, respectively. A high proportion of patients already had detectable antibodies for each influenza strain at baseline. Geometric mean titer ratios (post/prevaccination) were ≥2.5 for all groups and strains, except for H1N1 in the 14-mg group (2.3). The proportion of patients with a prevaccination titer

CONCLUSION: Teriflunomide-treated patients generally mounted effective immune responses to seasonal influenza vaccination, consistent with preservation of protective immune responses.

CLASSIFICATION OF EVIDENCE: This study provides Class II evidence that teriflunomide generally does not adversely impact the ability of patients with RMS to mount immune responses to influenza vaccination.

Bar-Or A, Freedman MS, Kremenchutzky M, Menguy-Vacheron F, Bauer D, Jodl S, Truffinet P, Benamor M, Chambers S, O'Connor PW.

Source: Neurology. 2013 Jul 12. [Epub ahead of print] & Pubmed PMID: 23851964 (31/07/13)

Genzyme receives positive CHMP opinion for Lemtrada™ (alemtuzumab) in Europe(28/06/13)

CHMP also Recommends NAS Designation for Aubagio® (teriflunomide) Following Positive Opinion on Approval in March 2013

Genzyme announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for approval of Lemtrada™ (alemtuzumab) for the treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease defined by clinical or imaging features.

In addition, the CHMP issued a positive opinion on new active substance designation (NAS) for Aubagio® (teriflunomide). Earlier this year, the CHMP issued a positive opinion recommending the approval of Aubagio for the treatment of adult patients with relapsing remitting MS.

The European Commission (EC) is expected to render a final decision to grant marketing authorizations for Lemtrada and Aubagio in the EU in the coming months.

“Today’s CHMP opinions set the stage for the approval of two important new treatment options for MS patients. Treatments to-date have addressed some of the unmet needs in MS, but still have limitations,” said David Meeker, MD, Genzyme President and CEO. “Upon approval, physicians will have the ability to prescribe Lemtrada for appropriate relapsing remitting patients based on their impressions of clinical or imaging characteristics regardless of duration of disease or treatment history. Expectations among the MS community are high for LEMTRADA and with today’s positive CHMP opinion we are a step closer to making this very innovative treatment available for MS patients in Europe.”

The positive CHMP opinion for approval of Lemtrada was based on data from the CARE-MS I and CARE-MS II trials, in which Lemtrada was significantly more effective than Rebif® (subcutaneous interferon beta-1a 44 mcg three times weekly) at reducing relapse rates. In CARE-MS II, accumulation of disability was significantly slowed in patients given LEMTRADA vs. Rebif, and importantly, patients treated with Lemtrada were significantly more likely to experience improvement in pre-existing disability.

“Today’s announcement from Genzyme represents a key milestone in the extensive program evaluating Lemtrada in multiple sclerosis,” said Professor Alastair Compston, Head of the Department of Clinical Neurosciences at the University of Cambridge, United Kingdom. “The superior efficacy of Lemtrada vs. Rebif in the clinical trials, which was sustained despite infrequent administration, represents an approach to treatment that promises to reshape the future for many people with active relapsing-remitting multiple sclerosis.”

Lemtrada has a novel dosing and administration schedule of two annual treatment courses. The first treatment course of LEMTRADA is administered via intravenous infusion on five consecutive days, and the second course is administered on three consecutive days, 12 months later.

The Lemtrada clinical development program included two randomized Phase III studies comparing treatment with Lemtrada to Rebif in patients with relapsing-remitting MS who had active disease and were either new to treatment (CARE-MS I) or who had relapsed while on prior therapy (CARE-MS II), as well as an ongoing extension study. A large randomized Phase II study provided the foundation for the Phase III program.

Safety results were consistent across both the CARE-MS I and CARE-MS II studies. The most common adverse events associated with LEMTRADA were infusion-associated reactions, including headache, rash, fever, nausea and hives. Infections were common in both the Lemtrada and Rebif groups. Infections more common on Lemtrada treatment included upper respiratory and urinary tract infections, herpes viral infections, and influenza. Most infusion-associated reactions and infections were mild to moderate in severity and responded to standard treatments.

In both CARE-MS I and CARE-MS II, the incidence of serious adverse events was similar between the two treatment arms. As previously reported, autoimmune disorders were more frequent in patients treated with LEMTRADA, primarily autoimmune thyroid disease which was observed in an estimated 36% of patients during extended follow-up. Immune thrombocytopenia (ITP) developed in 1.4 percent of Lemtrada-treated patients through extended follow-up and 0.3% developed glomerulonephritis. Autoimmune disorders were detected soon after onset through a monitoring program, and were generally managed using standard treatments.

A comprehensive risk management program has been proposed to support early detection and management of adverse events.

In the U.S. the FDA has accepted for review the company’s supplemental Biologics License Application (sBLA) file seeking approval of Lemtrada (alemtuzumab) for the treatment of relapsing multiple sclerosis (RMS). FDA recently extended the review cycle for Lemtrada by three months; no additional clinical studies have been requested, therefore FDA action on the application is expected in late 2013.

Source: Genzyme (28/06/13)

Aubagio® delays onset of clinically definite multiple sclerosis, study(25/04/13)

Genzyme, a Sanofi company, announced today positive top-line results from the TOPIC trial for Aubagio (teriflunomide). The trial was designed to assess whether early initiation of Aubagio (teriflunomide) in patients who experienced their first neurological symptoms consistent with Clinically Isolated Syndrome (CIS) can prevent or delay conversion to clinically definite multiple sclerosis (CDMS).

Clinically isolated syndrome (CIS) is defined as a first clinical attack with features suggestive of MS. It typically occurs in young adults and is often a prelude to CDMS.

In the TOPIC trial, patients receiving Aubagio 14 mg and 7 mg were significantly less likely to develop CDMS, defined as occurrence of a second clinical attack, the primary endpoint, as compared to placebo. Additional results, including key secondary and tertiary objectives, will be presented at a forthcoming scientific meeting.

“Clinically Isolated Syndrome (CIS) is often a prelude to clinically definite multiple sclerosis, and early treatment has proved beneficial,” said Dr. Aaron E. Miller, Medical Director, The Corinne Goldsmith Dickinson Center for Multiple Sclerosis, Mount Sinai Medical Center. “These findings are important as there is an unmet need for an efficacious oral option for patients at this stage of disease.”

The average duration of Aubagio exposure in TOPIC was approximately 16 months. Adverse events observed in the trial were consistent with previous clinical trials with Aubagio in MS. The most common types of adverse events reported more frequently in the Aubagio arms were ALT (Alanine transaminase) elevations, nasopharyngitis, headache, hair thinning, diarrhea and paresthesia. There were no deaths reported in either teriflunomide group over the course of the study. There was one death due to suicide in the placebo arm. The rate of treatment discontinuation due to adverse events was similar across treatment arms (9.1 percent in placebo arm, compared to 12.1 percent in 7 mg teriflunomide arm and 8.3 percent in 14 mg teriflunomide arm).

“Aubagio is the only oral marketed MS therapy to successfully be studied in CIS and we are very pleased by these topline results which further reinforce the consistent efficacy and potential for treating a broad spectrum of MS patients,” said Genzyme President and CEO, David Meeker, MD. “We remain committed to addressing unmet needs in MS through new areas of research and delivery of differentiated therapies for this devastating disease.”

The trial compared treatment with either 14 mg or 7 mg once-daily, oral Aubagio against placebo. This double-blind, multi-center trial enrolled 618 patients who had experienced a first acute or sub-acute, well-defined neurological event consistent with demyelination, as well as onset of MS symptoms within 90 days of randomization, and MRI scan showing two or more T2 lesions characteristic of MS.

Aubagio is approved in the U.S., Australia and Argentina for the treatment of relapsing forms of MS. Marketing applications for Aubagio are also under review by regulatory authorities globally.

The ongoing Aubagio clinical development program, involving more than 5,000 patients in 36 countries, is amongst the largest of any MS therapy. Some patients in extension trials have been treated for up to 10 years.

Source: Fort Mill Times © Copyright 2013, Fort Mill Times (25/04/13)

Aubagio® (teriflunomide) approved in Argentina for the treatment of relapsing multiple sclerosis(09/04/13)

Genzyme, a Sanofi company, announced Argentina’s National Administration of Drugs, Food and Medical Technology (ANMAT) has approved once-daily, oral Aubagio® 14 mg as a new treatment indicated for patients with relapsing forms of multiple sclerosis (MS).

“Studied in one of the largest clinical trial programs of any MS treatment, Aubagio has had consistent effects across all the important measures of MS disease activity including slowing the progression of disability, reducing the number of brain lesions as detected by MRI and reducing relapses. The clinical data supporting Aubagio confirm its importance as a new treatment option for MS patients,” said Dr. Jorge Correale, Head of Neuroimmunology and Demyelinating Diseases, Raul Carrea Institute for Neurological Research FLENI, Argentina.

The decision by ANMAT represents the first approval for once-daily, oral Aubagio in Latin America. Aubagio is also approved in both the United States and Australia, with additional marketing applications under review by regulatory authorities around the world.

“The approval in Argentina of once-daily, oral Aubagio represents another important advancement for the Genzyme MS Franchise,” said Bill Sibold, SVP, Head of MS Business, Genzyme. “Genzyme is committed to becoming leaders in MS and developing differentiated treatments that can address the diverse needs of the MS community. Now approved on three continents, Aubagio’s established efficacy and convenient dosing can provide many patients with an attractive alternative to frequent and potentially burdensome injections.”

The ANMAT approval of Aubagio was based on safety and efficacy data from the TEMSO (TEriflunomide Multiple Sclerosis Oral) trial. The ongoing Aubagio clinical development program, involving more than 5,000 patients in 36 countries, is amongst the largest of any MS therapy. Some patients in extension trials have been treated for up to 10 years.

“Aubagio, in its clinical studies, has shown favourable efficacy and a well-characterised safety profile. With its once-daily oral administration and tolerability, Aubagio should contribute positively to the care of patients with Multiple Sclerosis,” said Dr. Edgardo Cristiano, Head of the Neurology Department of the Hospital Italiano de Buenos Aires, Argentina.

About Aubagio®

Aubagio is an immunomodulator with anti-inflammatory properties. Although the exact mechanism of action for Aubagio is not fully understood, it may involve a reduction in the number of activated lymphocytes in the central nervous system (CNS).

Source: Financial Post © 2013 National Post (09/04/13)

Aubagio (teriflunomide) and Tecfidera (BG-12) move closer to European approval(22/03/13)

The Committee for Medicinal Products for Human Use (CHMP) issued positive opinions on two new MS therapies. Recommending the granting of a marketing authorisation for the medicinal product Tecfidera 120 mg and 240 mg, gastro-resistant hard capsules, intended for the treatment of adult patients with relapsing remitting multiple sclerosis and Aubagio 14 mg film-coated tablet intended for the treatment of multiple sclerosis.

The Committee also concluded that the active substance contained in Aubagio, teriflunomide, could not be considered to be a new active substance. It is expected that Sanofi-aventis will appeal against this conclusion.

The full Summaries Of Opinion can be read here: Tecfidera , Aubagio 

Source: The Committee for Medicinal Products for Human Use (CHMP) (22/03/13)

Genzyme blitzes Australian MS market with free oral drug teriflunomide(27/11/12)

Drug company Genzyme has launched an aggressive campaign to get its new multiple sclerosis drug teriflunomide prescribed free of charge to patients, in a controversial patient familiarisation program announced the same day the medicine was licensed in Australia.

Each participating neurologist will be able to sign up 10 patients for the once-daily immune system pill, sold under the brand name Aubagio and intended for people with moderate to severe disease, a spokesman said – about 14,000 mainly young adult Australians.

Any patient prescribed the drug, which competes with interferons, could continue on it indefinitely while the company awaited a Pharmaceutical Benefits Scheme subsidy ruling.

But Agnes Vitry, from the University of South Australia’s School of Pharmacy and Medical Sciences, said familiarisation programs were intended to pressure the government into unwarranted subsidies and could have “disastrous consequences”.

“They can lead to a very rapid uptake of new drugs whose safety is still very uncertain and aim to induce swapping from older drugs without medical need but with potential safety issues,” she wrote in a submission to the Australian Consumer and Competition Commission’s review of Medicines Australia’s Code of Conduct.

Because teriflunomide was a powerful drug with potentially serious side-effects, “I would not trust information given by the drug company but would wait for independent assessments,” Dr Vitry told Neurology Update’s sister publication, 6minutes.

Teriflunomide stays in the body for up to two years and may cause liver damage and birth defects.

Source: Neurology Update (27/11/12)

Australian TGA approves Aubagio to treat relapsing forms of MS(22/11/12)

Genzyme, a Sanofi company, has announced that the Australian Therapeutic Goods Administration (TGA) has approved Aubagio® (teriflunomide) 14 mg as a new once-daily, oral treatment indicated for patients with relapsing forms of multiple sclerosis (MS).

The TGA approval will enable health professionals to prescribe Aubagio 14 mg in Australia, which is now the second country to gain marketing authorization for the treatment, following FDA approval in September.

"We are very pleased with the TGA approval of Aubagio that makes available a new option for healthcare professionals, and people living with MS in Australia who may benefit from this once-daily, oral treatment," said Bill Sibold, Head of Multiple Sclerosis, Genzyme. "The availability of Aubagio in the U.S. and subsequent registration in Australia not only demonstrates our continued progress, it also reflects our commitment to deliver differentiated treatments and provide access for patients globally."

The TGA's approval of Aubagio was based on safety and efficacy data from the TEMSO (TEriflunomide Multiple Sclerosis Oral) trial. The ongoing Aubagio clinical development program, involving more than 5,000 patients in 36 countries including Australia, is amongst the largest of any MS therapy. Some patients in extension trials have been treated for up to 10 years.

"For some people living with MS, the additional burden of injectable therapies administered daily to weekly can sometimes be a struggle," said Associate Professor John King, Senior Neurologist, Royal Melbourne Hospital, who participated in the clinical trials for Aubagio. "It is exciting to see a new oral treatment that has been shown to both reduce relapses and slow the progression of disability. This is an encouraging development for the MS community."

Aubagio is an immunomodulator with anti-inflammatory properties. Although the exact mechanism of action for Aubagio is not fully understood, it may involve a reduction in the number of activated lymphocytes in the central nervous system (CNS).

"We welcome the advent of a new oral treatment option for MS patients in Australia," said Professor Bill Carroll, Chairman of MS Research Australia. "It is important for people with MS and their clinicians to have access to a range of well-tolerated and convenient therapies that may reduce the impact of the disease on their lives and suit their lifestyle."

Aubagio is marketed in the U.S. and now Australia. Marketing applications for AUBAGIO are under review by the European Medicines Agency (EMA) and other regulatory authorities.

Source: News-Medical.Net (22/11/12)>

Oral Aubagio® (teriflunomide) study confirms significant impact on disability(15/10/12)

Genzyme, a Sanofi company announced today that key data from the TOWER trial were presented at the 28th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). In the study, once-daily, oral Aubagio® 14 mg significantly reduced the annualized relapse rate and slowed progression of disability in patients with relapsing forms of multiple sclerosis (MS) compared to placebo. In addition, the proportion of patients treated with Aubagio who were relapse-free was significantly higher compared to placebo.

TOWER (Teriflunomide Oral in people With relapsing multiplE scleRosis) is a randomized, double-blind Phase III trial that enrolled 1,169 patients with relapsing MS across 26 countries and compared 7 mg or 14 mg once-daily, oral Aubagio against placebo. The company announced positive top-line results in June. In September, the FDA approved AUBAGIO as a once-daily oral treatment for patients with relapsing forms of MS. Marketing applications for Aubagio are currently under review by the EMA and other regulatory authorities.

“Slowing the progression of disability is a major goal in treating MS and remains a significant unmet need for many patients,” said Ludwig Kappos, M.D., Chair of Neurology, University Hospital Basel, Switzerland, who presented the key TOWER results. “The TOWER study results are consistent with the Phase lll TEMSO data, both in terms of the effect on progression of disability and the manageable safety profile of Aubagio.”

TOWER data presented for the first time today for the 14 mg dose include:

A 36.3 percent reduction in annualized relapse rate (ARR=0.319), the primary endpoint of the trial, as compared to placebo (ARR=0.501) (p=0.0001); Fifty-two percent of patients treated with this dose were also relapse-free, meaning they did not experience any relapses during the study, compared to 38 percent with placebo (37 percent risk reduction; p<0.0001).

A 31.5 percent reduction in the risk of 12-week sustained accumulation of disability, the main secondary endpoint, as measured by the Expanded Disability Status Scale (EDSS), compared to placebo (p=0.0442).

In addition, a 22.3 percent reduction in annualized relapse rate (ARR=0.389) was observed in patients treated with Aubagio 7 mg compared to placebo (p=0.189); Further, 55 percent of patients treated with 7 mg AUBAGIO were relapse-free, as compared with 38 percent on placebo (p=0.0016). There was no statistically significant difference observed between Aubagio 7 mg and placebo for the risk of 12-week sustained accumulation of disability.

“Aubagio is the first and only oral MS therapy to significantly slow the progression of disability in two Phase III trials,” said David Meeker, M.D., President and CEO, Genzyme. “The convenience of a once daily oral therapy offers a meaningful alternative for patients wanting to avoid the burden of regular injections.”

Patients who completed the trial were followed for a period between 48 and 173 weeks. The average duration of Aubagio exposure in TOWER was 18 months.

Adverse events observed in the trial were consistent with those seen in previous studies of Aubagio in MS. The proportion of patients with treatment-emergent adverse events was similar across all treatment arms. The most common adverse events reported more frequently in the Aubagio arms were headache, ALT (Alanine aminotransferase) elevations, hair thinning, diarrhea, nausea and neutropenia. As previously reported, there was one death from a respiratory infection in the placebo arm and three deaths in the teriflunomide arms from a motor vehicle accident, suicide and sepsis.

The FDA has approved Aubagio as a once-daily, oral immunomodulator indicated for patients with relapsing forms of multiple sclerosis (MS). The ongoing Aubagio clinical development program, involving more than 5,000 patients in 36 countries, is among the largest of any MS therapy. Some patients in extension trials have been treated up to 10 years.

Aubagio is an immunomodulator with anti-inflammatory properties. Although the exact mechanism of action for Aubagio is not fully understood, it may involve a reduction in the number of activated lymphocytes in the central nervous system (CNS).

The U.S. Aubagio label includes a boxed warning citing the risk of hepatotoxicity and, teratogenicity (based on animal data). In MS clinical studies included in the U.S. label, the incidence of serious adverse events were similar among AUBAGIO and placebo-treated patients. The most common adverse events associated with Aubagio in MS patients included increased ALT levels, alopecia, diarrhea, influenza, nausea and paresthesia.

The labeling for Aubagio was also informed by the estimated 2.1 million years of patient exposure globally since the launch of leflunomide, which is indicated in the U.S. for the treatment of rheumatoid arthritis. Aubagio is the principal active metabolite of leflunomide. Severe liver injury including fatal liver failure has been reported in patients treated with leflunomide.

About the TOWER Trial

TOWER is a Phase III, multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of AUBAGIO in patients with relapsing MS followed by an open-label extension period.

The TOWER study included patients ages 18 to 55. The primary endpoint was the annualized relapse rate, defined as the number of confirmed relapses per patient-year. The key secondary endpoint was time to disability progression confirmed for a minimum of 12-weeks. Safety variables were defined as adverse events reported by the patients or noted by the investigator during the study period.

Source: Genzyme (15/10/12)

Battle lines drawn in the MS oral drugs market(23/09/12)

For years, patients with multiple sclerosis had to endure injection therapies to stave off the horrible disease. Oral medications have finally emerged from development recently, and it turns out the competition is heating up fast: Results arrived on two major clinical trials for Biogen Idec's own oral MS drug, BG-12, and the data looks rock-solid. With the MS market suddenly red-hot, will Biogen's latest success propel the company to higher heights?

Mopping up the competition

Biogen's two phase 3 trials for BG-12 came out in Wednesday's New England Journal of Medicine with promising results. The two trials demonstrated strong efficacy for BG-12, with chronic relapses falling 44% to 51% at the two-year mark. Given that drugs currently used to combat MS relapses typically demonstrate only a 30% improvement, BG-12's success looks sharp.

While the FDA won't rule on BG-12's approval until later in the year, Biogen's drug looks to become just the third oral medication for MS on the market. Sanofi's Aubagio received the green light from the FDA earlier this month, following Novartis's Gilenya, the first oral MS treatment launched in 2010.

Unfortunately for Biogen's two competitors, their drugs come with serious questions over efficacy and side effects. Gilenya has caused numerous headaches for Novartis, with the FDA issuing a restrictive label for the drug after a patient died soon after beginning treatment. While the connections between the death and the drug were unclear, the fact that Gilenya also can slow patient heart rates -- and that patients are recommended to stay in a hospital for six hours after the first dose -- aren't helping Novartis' PR department.

Sanofi might not face the same sort of lethal problems with Aubagio, but regardless of Aubagio's warm reception around projected future sales, early signs show that BG-12 is simply a better product. In one trial, Aubagio failed to beat the Rebif injection treatment offered by Pfizer with Aubagio sporting only a 30% relapse reduction. BG-12 leads with a considerable advantage in a head-to-head matchup of efficacy.

Concerns and answers

Ironically, the hurdles hit by these two drugs -- Gilenya in particular -- could come back to haunt Biogen. With doctors used to effective injection medications for MS, the problems of the past could make individual practitioners hesitant to dole out a third oral treatment. National MS Society Chief Research Officer Timothy Coetzee cautioned BG-12's spread on this very issue, stating, "My guess is that the injectables will remain an important treatment option." He warned that a wide-scale replacement of injection treatments with oral drugs is still up in the air.

Still, BG-12 is a potent drug. The twice-daily treatment in one clinical trial proved to reduce new MS-linked brain lesions by 71%. The drug also lacks the problematic side effects of Gilenya, with the most common problems being digestive issues such as abdominal pain and diarrhea. Such side effects also diminished in number in the clinical trials after the first treatment month.

Additionally, Biogen has plenty of ways to combat MS on the market already. Its MS injection therapy developed jointly with Elan Tysabri, is prescribed for first-line MS treatment in Europe. Tysabri still recorded 69,000 patients as of July and grew year-over-year annual revenue by more than 10% in 2011 for Biogen.

BG-12's U.S. patents won't expire until 2019 at the earliest, so if it's approved, Biogen will have plenty of time to make inroads on a lucrative and growing MS market. Biogen further estimates that BG-12 would hold eight years of data exclusivity and an additional two years of market exclusivity in the European Union, effectively stringing out maximum sales in the Western world's most powerful consumer markets until the next decade.

Biogen's steady stream of optimism

Biogen's still a solid company with a strong financial future on top of all that. It boasts a steady pipeline of 12 drugs and therapies in phase 2 trials or later, including BG-12. The company's best-selling drug, Avonex, took in more than 50% of the company's revenues, and Biogen holds exclusive rights on the drug until 2026.

The strong majority of Biogen's $5 billion in annual revenues stemmed from MS treatments in 2011 -- a market that will reward Biogen and its shareholders even more as it grows from a current $9.6 billion market last year to an estimated $14 billion by 2015, according to JPMorgan Chase projections. If medical professionals sign on to the prescription of oral MS treatments, it's common sense to think that patients would go for the hassle-free therapies over painful injections -- allowing BG-12 and Biogen to further tighten the company's grip on this market.

Don't bet the farm on Biogen before the FDA rules on BG-12's approval, but for right now, everything's looking optimistic for this MS drug. It's up for debate whether BG-12 will hit superstar status, but with Gilenya already selling reasonably well and projections for Aubagio high, BG-12 could take the lead in a promising market. Biogen may be trading at all-time highs, but the coming returns could soundly trump what we've seen so far from this booming biotech stock.

Source: Daily Finance © Copyright 2012 AOL Inc.(23/09/12)

Oral multiple sclerosis pill Aubagio® gets U.S. approval(13/09/12)

Sanofi SA has won U.S. approval for its multiple sclerosis pill Aubagio - one of the two treatments for the chronic disease that could return the French drugmaker to growth after several blockbuster drugs lost patent protection.

The drug has been shown to be less effective than some rivals but has milder side effects and analysts say it could find favour among newly diagnosed patients. Around 35 percent to 40 percent of multiple sclerosis (MS) sufferers prefer to take no medication rather than face unwanted side effects.

"In a clinical trial, the relapse rate for patients using Aubagio was about 30 percent lower than the rate for those taking a placebo," Russell Katz, director of the Division of Neurology Products at the Food and Drug Administration, said in a statement on Wednesday.

Aubagio is expected to launch on the U.S. market in a few weeks, a spokeswoman for Sanofi unit Genzyme said.

Multiple sclerosis, which has no cure, affects 2.5 million people worldwide. It is a chronic, often disabling disease that attacks the central nervous system and can lead to numbness, paralysis and loss of vision.

MS drugs Gilenya by Novartis and Biogen Idec Inc's BG-12 are expected to dominate a market that JPMorgan analysts predict growing to $14 billion in 2015 from $9.6 billion last year.

Aubagio is seen grabbing a much smaller chunk of this market, reaching modest sales of $353 million in the United States and five major European countries by 2020, according to business intelligence firm Datamonitor.

Cheuvreux analyst Marcel Brand, who has a more optimistic forecast, predicts peak sales of Aubagio of 1.48 billion euros by 2018. "Although Aubagio is not as effective on relapse rates as Gilenya, it's free of its longer-term side effects," he said.

Patients taking Gilenya have to be monitored because the drug causes the heart rate to slow down in the first hours after ingestion.

European regulators are expected to give their response to Aubagio in the first quarter of 2013.

Compared with older therapies for MS, Aubagio has the advantage of being taken orally but it has produced less impressive results in clinical tests than other oral treatments and has failed to show it was better than Merck's Rebif, a commonly used injectable drug for MS.

In addition to Aubagio, Sanofi has filed for approval for MS injectable drug Lemtrada.

In a recent setback, the FDA asked Sanofi to refile its marketing application for Lemtrada. If it wins approval, the drug could be launched in 2013.

The most common side effects associated with Aubagio include increased levels of the enyzme alanine transaminase, which can indicate damage to the liver, as well as hair loss, diarrhea, influenza, nausea and numbness of the skin, Sanofi said.

The ongoing Aubagio clinical development program involves more than 5,000 patients in 36 countries. Some patients in extension trials have been treated for up to 10 years, the company said.

Source: Yahoo! News c) Copyright Thomson Reuters 2012 (13/09/12)