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FDA approves label change for oral MS drug Aubagio(21/10/14)

The US Food and Drug Administration (FDA) approved Genzyme’s application to include new information about its multiple sclerosis drug teriflunomide (Aubagio) on its label.

The new labeling content is efficacy and safety data from two Phase III trials of the drug. One trial, a study known as TOPIC is described in the Sept., 2014 issue of The Lancet Neurology. In it Aaron Miller, MD and colleagues report that in 618 relapsing-remitting multiple sclerosis patients assigned to the drug or placebo those who got the drug had a significantly reduced risk of relapse. The patients got a single daily oral dose of either 14 mg or 7 mg (or placebo) for up to 108 weeks.

The study was conducted from Feb 13, 2008 to Aug. 22, 2012 at 112 medical centers in 20 countries. The patients getting teriflunomide did better than placebo at either dosage at preventing relapses without serious side effects.

Miller is medical director of The Corinne Goldsmith Dickinson Center for Multiple Sclerosis at the Mount Sinai Hospital in New York, NY. In a statement from Genzyme, Miller said “Aubagio is the only oral multiple sclerosis treatment that has demonstrated a positive effect on disability progression in two Phase III clinical studies and is the only oral therapy with supporting published efficacy data on the treatment of patients who have experience a first clinical attack.”

The drug was originally approved for US use in 2012. Pooled data from TOPIC and two other studies involving 2,000 subjects found that though patients experienced adverse events including decreased white blood cell count, peripheral neuropathy, skin reactions and increased blood pressure, the rate at which the subjects reported these events was about the same as in subjects who were taking placebos.

The drug is an immunomodulator with anti-inflammatory properties. It is believed to reduce the number of activated lymphocytes in the central nervous system. It is contraindicated for patients with severe liver problems and in women who are pregnant or may become pregnant since animal studies indicate teratogenicity.

Source: HCPLive Copyright HCPLive 2006-2014 Intellisphere, LLC (21/10/14)

Early treatment with Teriflunomide may slow MS development(23/09/14)

Oral teriflunomide for patients with a first clinical episode suggestive of multiple sclerosis (TOPIC): a randomised, double-blind, placebo-controlled, phase 3 trial.

Miller AE, Wolinsky JS, Kappos L, Comi G, Freedman MS, Olsson TP, Bauer D, Benamor M, Truffinet P, O'Connor PW; TOPIC Study Group.

Abstract

BACKGROUND: Teriflunomide is a once-daily oral immunomodulator approved for the treatment of relapsing-remitting multiple sclerosis. We aimed to assess the efficacy and safety of teriflunomide in patients with a first clinical episode suggestive of multiple sclerosis.

METHODS: In this randomised, double-blind, placebo-controlled, parallel-group study, we enrolled patients aged 18-55 years with clinically isolated syndrome (defined as a neurological event consistent with demyelination, starting within 90 days of randomisation, and two or more T2-weighted MRI lesions ≥3 mm in diameter) from 112 centres (mostly hospitals) in 20 countries. Participants were randomly assigned (1:1:1) in a double-blind manner (by an interactive voice response system) to once-daily oral teriflunomide 14 mg, teriflunomide 7 mg, or placebo, for up to 108 weeks. Patients, staff administering the interventions, and outcome assessors were masked to treatment assignment. The primary endpoint was time to relapse (a new neurological abnormality separated by ≥30 days from a preceding clinical event, present for ≥24 h in the absence of fever or known infection), which defined conversion to clinically definite multiple sclerosis. The key secondary endpoint was time to relapse or new gadolinium-enhancing or T2 lesions on MRI, whichever occurred first. The primary outcome was analysed for the modified intention-to-treat population; safety analyses included all randomised patients who were exposed to the study drug, as treated. This trial is registered with ClinicalTrials.gov, number NCT00622700.

FINDINGS: Between Feb 13, 2008, and Aug 22, 2012, 618 patients were enrolled and randomly assigned to teriflunomide 14 mg (n=216), teriflunomide 7 mg (n=205), or placebo (n=197). Two patients in each of the teriflunomide groups did not receive the study drug, so the modified intention-to-treat population comprised 214 patients in the teriflunomide 14 mg group, 203 in the teriflunomide 7 mg group, and 197 in the placebo group. Compared with placebo, teriflunomide significantly reduced the risk of relapse defining clinically definite multiple sclerosis at the 14 mg dose (hazard ratio [HR] 0·574 [95% CI 0·379-0·869]; p=0·0087) and at the 7 mg dose (0·628 [0·416-0·949]; p=0·0271). Teriflunomide reduced the risk of relapse or a new MRI lesion compared with placebo at the 14 mg dose (HR 0·651 [95% CI 0·515-0·822]; p=0·0003) and at the 7 mg dose (0·686 [0·540-0·871]; p=0·0020). During the study, six patients who were randomly assigned to placebo accidently also received teriflunomide at some point: four received 7 mg and two received 14 mg. Therefore, the safety population comprised 216 patients on teriflunomide 14 mg, 207 on teriflunomide 7 mg, and 191 on placebo. Adverse events that occurred in at least 10% of patients in either teriflunomide group and with an incidence that was at least 2% higher than that with placebo were increased alanine aminotransferase (40 [19%] of 216 patients in the 14 mg group, 36 [17%] of 207 in the 7 mg group vs 27 [14%] of 191 in the placebo group), hair thinning (25 [12%] and 12 [6%] vs 15 [8%]), diarrhoea (23 [11%] and 28 [14%] vs 12 [6%]), paraesthesia (22 [10%] and 11 [5%] vs 10 [5%]), and upper respiratory tract infection (20 [9%] and 23 [11%] vs 14 [7%]). The most common serious adverse event was an increase in alanine aminotransferase (four [2%] and five [2%] vs three [2%]).

INTERPRETATION: TOPIC is to our knowledge the first study to report benefits of an available oral disease-modifying therapy in patients with early multiple sclerosis. These results extend the stages of multiple sclerosis in which teriflunomide shows a beneficial effect.

FUNDING: Genzyme, a Sanofi company.

Source: Lancet Neurol. 2014 Oct;13(10):977-86. doi: 10.1016/S1474-4422(14)70191-7. Epub 2014 Sep 2.& Pubmed PMID: 25192851 © 2014 Elsevier Ltd (23/09/14)

MS drugs Lemtrada and Aubagio launched in Ireland(03/09/14)

Genzyme's plans to grow its multiple sclerosis business in Europe continued with the launch of two new treatments in the Republic of Ireland.

The company, which serves as the biotech arm of French pharma firm Sanofi, today launched the injectable Lemtrada (alemtuzumab) in the country just weeks after oral multiple sclerosis (MS) treatment Aubagio (teriflunomide) hit the market.

Lemtrada will be made available to adults with active relapsing-remitting multiple sclerosis (RRMS), in accordance with its approval from the EC. It is to be given as an intravenous infusion in two annual treatment courses.

Aubagio is also available for adults with active RRMS, although it is one of several new MS treatments that come in an oral formulation, offering greater convenience to patients. It is to be taken once daily.

According to Genzyme, there are 8,000 people in Ireland with MS and around 85% will be affected by RRMS.

The launch of Lemtrada follows a recommendation in July this year from the National Centre for Pharmacoeconomics (NCPE), which provides guidance on what drugs should be reimbursed on Ireland's healthcare system to the Health Service Executive (HSE).

By contrast, Aubagio was turned down by the NCPE in June with after its assessment found that the drugs cost was not justified by its benefits.

However, in a conversation with PMLiVE, Henry Featherstone, director of public affairs at Genzyme UK & Ireland confirmed that Genzyme has since held discussions with the HSE and they have agreed that the drug can be reimbursed in Ireland.

As for where the drugs fit on the MS treatment pathway, Featherstone said that the broad indications for both products allowed doctors to discuss suitable options with patients. Further down the line, however, it's possible that Aubagio will be better suited as a first-line treatment for people with MS, while Lemtrada will be reserved for more aggressive forms of the disease.

"We hope to have these treatments available to as many people with MS as possible," Featherstone told PMLiVE. "We passionately believe in these products."

Backing Featherstone's belief, both drugs are making headway in western Europe where Lemtrada had revenues of €10m for the first six months of the year and Aubagio had revenues of €38m.

It's a different story for Lemtrada in the US, however, as the drug was turned down by the FDA at the start of 2014, much to the shock of Genzyme and Sanofi.

The decision, which was based on concerns over the drug's safety, drew criticism from the healthcare community and dozens of US doctors added their name to an open letter to the FDA to appeal the negative guidance.

Source: PMLive © PMGroup Worldwide Ltd 2014 (03/09/14)

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)