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SMC first to introduce oral Gilenya® as a first line treatment option for people with a severe form of MS(14/10/14)

SMC first to introduce oral Gilenya® as a first line treatment option for people with a severe form of MS

• Scottish people with a severe form of relapsing remitting multiple sclerosis are first in UK to get access to once daily pill fingolimod as a first line treatment option1
• Once daily pill fingolimod reduces the risk of relapses by 67% compared to placebo2

Today, the Scottish Medicines Consortium (SMC) has accepted once daily pill fingolimod (Gilenya®) as a first line option for people with a severe form of relapsing remitting MS, which has been shown to reduce the risk of relapses by 67% compared to placebo.1,2 This is the first time that an oral treatment has been made available as a first line treatment option for people with this severe form of MS - known as rapidly evolving severe relapsing remitting MS (RES RRMS).1

The SMC heard from patient groups that MS is an incurable progressive disease with devastating effects on those with the condition and their families.1 Symptoms can include intense pain, mobility problems, severe depression, fatigue, incontinence and loss of vision.1 MS affects over 100,000 people in the UK, with rates highest in Scotland.3,4

85% of people with MS are diagnosed with the relapsing remitting form - when symptoms flare up aggressively - known as relapses.5 There are different types of RRMS, including highly active and RES RRMS.6 In September 2012, the SMC agreed to reimburse fingolimod for people with highly active RRMS who are failing on first line interferon injections.7 Today’s decision means that fingolimod is now also reimbursed for RES RRMS – when a person has two or more disabling relapses in one year with associated MRI changes.1 The SMC’s decision to broaden access to fingolimod means this is the first time that people with this more severe form of RRMS will have the choice of a once daily pill as a first line treatment option.1

Prior to today’s decision, only one SMC approved treatment was available for people with RES RRMS – a hospital-based infusion called natalizumab required every 28 days.1 Fingolimod is a once daily pill that can be taken at home after the first dose, avoiding the need to travel to hospital every month. It has been shown to reduce relapses by 67% compared to placebo in those with RES RRMS (ARR 0.24 for fingolimod and 0.74 for placebo).2 The analysis was conducted in a subgroup of patients from the original phase III FREEDOMS trial.

Scottish patients with RES RRMS will have access to once daily pill fingolimod as a first line treatment option before those in the rest of the country. This is because the SMC process allows manufacturers to submit new data at any time. NICE is set to review fingolimod alongside a range of other MS treatments in 2015. This means that people with this severe form of RRMS north of the border will have an increased choice of first line treatments before their southern counterparts.

Today’s announcement follows a series of recent decisions by the European Commission and NHS England to extend the use of fingolimod to a wider group of people, just three years after its original licence was granted in March 2011.

To date, more than 100,000 people worldwide have been treated with fingolimod in clinical trials and in the post-marketing setting.8 Fingolimod has been approved in 80 countries.8

References 1. SMC assessment of fingolimod (as hydrochloride), 0.5mg hard capsules (Gilenya®). October 2014
2. Devonshire V, Havrdová E, Radue EW et al. Relapse and disability outcomes in patients with multiple sclerosis treated with fingolimod: subgroup analyses of the double-blind, randomised, placebo-controlled FREEDOMS study. Lancet Neurol. 2012; 11:420-28
3. The Scottish Parliament. Briefing for the Public Petitions Committee. http://www.scottish.parliament.uk/ResearchBriefingsAndFactsheets/Petitions%20briefings%20S3/PB10-1353.pdf Last accessed 10 October 2014.
4. MS Society. What is MS? http://www.mssociety.org.uk/about_ms/what_is_ms/index.html Last accessed 10 Oct 2014
5. MS Society. http://www.mssociety.org.uk/what-is-ms/types-of-ms/relapsing-remitting-rrms Last accessed 10 October 2014
6. MS Trust. http://www.mstrust.org.uk/atoz/types.jsp Last accessed 10 October 2014
7. SMC assessment of fingolimod (as hydrochloride), 0.5mg hard capsules (Gilenya®). SMC No. (763/12). 12 March 2012
8. Gilenya World Watch. http://www.gilenya-world-watch.com/English.html Last accessed 10 October 2014
9. European Commission. Community register of medicinal products for human use. Gilenya. http://ec.europa.eu/health/documents/community-register/html/h677.html Last accessed 10 October 2014.
10. NHS England commissioning guideline for Gilenya. June 2014

Source: Novartis (14/10/14)

MS drug Gilenya in new therapeutic indication: Added benefit not proven(13//10/14)

The immunosuppressive drug fingolimod (trade name: Gilenya) was approved for an expanded therapeutic indication in May 2014: It is now also available for adults with highly active relapsing remitting multiple sclerosis (RRMS) who had received other pretreatment than interferon beta (IFN-β). 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 the drug offers an added benefit over the appropriate comparator therapy in this patient group.

According to the findings, such an added benefit is not proven: For some of the patients, the drug manufacturer presented no data. For other patients, the available study data either showed no differences between the treatment groups, or the data were not evaluable.

G-BA specifies appropriate comparator therapy

The Federal Joint Committee (G-BA) distinguishes between two patient groups for the assessment: In patients with highly active RRMS despite full previous treatment (no interferon beta), fingolimod was to be compared with glatiramer acetate or interferon beta. In patients with incomplete previous treatment, the G-BA distinguishes between two cases for the appropriate comparator therapy: In patients who had received glatiramer acetate, this medication was to be optimized and continued. In patients who had received a different drug, treatment was to be changed to interferon beta or glatiramer acetate.

Only data of few study participants relevant for the assessment

One relevant study was available for the early benefit assessment, an approval study on fingolimod (TRANSFORMS), which compared treatment with fingolimod versus treatment with IFN-β1a in adults with RRMS. However, the disease was rated as "highly active" in only nearly half of the 866 participants. Only 263 of these 402 patients had received full previous treatment. Only 42 participants, i. e. a little less than five percent of the total study population, had not been treated with interferon beta (17 patients in the fingolimod arm, 25 in the interferon beta arm). However, only these patients correspond to the subpopulation relevant for this benefit assessment, because it is only this subpopulation that fingolimod had received expanded approval for. The informative value of the results was considerably limited because only data of few participants were evaluable.

Differences between treatment arms not statistically significant

No deaths occurred during the total study duration of 12 weeks. There were differences between the fingolimod and the interferon beta group with regard to relapses and disability progression, but these were not statistically significant.

No evaluable data were available for the patient group for which fingolimod was newly approved regarding other aspects of the outcome "morbidity", e.g. fatigue or activities of daily living, and for the outcome "health-related quality of life". One of the reasons for this is that different proportions of patients were not considered in the analysis.

There were group differences in side effects (serious adverse events and treatment discontinuation due to adverse events), which again were not statistically significant.

Dossier without relevant study on patients with incomplete treatment

In its dossier, the manufacturer presented no relevant study for patients who had not received full previous treatment.

In summary, an added benefit of fingolimod is therefore not proven for patients with highly active relapsing remitting multiple sclerosis (RRMS) who had received a different pretreatment than interferon beta.

Discrepancy between approval and study population

In 2011, fingolimod had been approved for two therapeutic indications: for rapidly progressive severe RRMS and for highly active RRMS that had been pretreated with interferon beta. For these two patient groups, IQWiG had published a dossier assessment according to AMNOG in January 2012.

In this first assessment the problem had already occurred that participants with different types of RRMS had been included in the relevant study, and that the authorities had then limited the approval to specific, relatively small patient groups. Since the first approval and assessment, the manufacturer apparently conducted no further studies for the expansion of approval.

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.

Source: Medical Xpress © Medical Xpress 2011-2014, Science X network (13//10/14)

Wider use of MS drug Gilenya approved in Europe(12/06/14)

The European Commission has endorsed the recent Committee for Medicinal Products for Human Use (CHMP) positive opinion recommending the expanded use of Swiss drug major Novartis’ drug Gilenya (fingolimod) for adult patients with highly active relapsing-remitting multiple sclerosis (RRMS).

The indication expansion will now give clinicians the flexibility to use fingolimod in the highly active RRMS group, for patients needing to switch from interferons as well as glatiramer acetate (Teva’s Copaxone) and other DMTs.

Prior to the indication expansion, fingolimod, which generated sales of nearly $2 billion last year, was limited for use in those patients with highly active RRMS not responding to an interferon.

The European Commission approval was based on a favourable review of the long-term efficacy and safety data for fingolimod and comes three years after the initial licence was granted in March 2011. Fingolimod is now approved in 80 countries and it is estimated that more than 91,500 patients have been treated with fingolimod in clinical trials and in the post-marketing setting.

.Fingolimod is the only established oral therapy approved by the UK’s drugs watchdog the National Institute for Health and Care Excellence (NICE) for the treatment of highly active RRMS that is effective across four key measures of MS disease activity – relapses, MRI lesions, brain volume loss and disability progression, the drugmaker noted. Novartis says it will work with the relevant European funding bodies to ensure that patients who meet these new criteria are able to access fingolimod in the near future.

Source: thepharmaletter(12/06/14)

MS drug Gilenya appears to slow brain volume loss in relapsing patients(01/05/14)

Novartis International AG announced new data showing that more patients with relapsing multiple sclerosis treated with Gilenya (fingolimod) achieved an average annual rate of brain volume loss within the range of those expected for healthy adults of a similar age vs. those patients taking placebo. People with multiple sclerosis experience shrinkage of the brain up to three to five times faster. This acceleration starts early in people with relapsing MS, even before symptoms are apparent.

"These data are impressive as they show that Gilenya slows brain volume loss in relapsing MS patients, an important indicator of disease activity," said David Epstein, Division Head, Novartis Pharmaceuticals.

Gilenya is an oral disease modifying therapy that works on four key measures of multiple sclerosis disease activity - relapses, MRI lesions, brain volume loss and disability progression.

Source: NASDAQ. (01/05/14)

CHMP issues positive opinion to expand EU label for Gilenya in RRMS(29/04/14)

Swiss drug giant Novartis said that the Committee for Medicinal Products for Human Use or CHMP has issued a positive opinion to expand the EU label for Gilenya (fingolimod) in relapsing remitting multiple sclerosis or RRMS.

The recommendation is to expand the label to include adult patients who have not responded to at least one disease-modifying therapy or DMT, including newly-approved oral DMTs. Gilenya is currently licensed in the EU for adult patients with RRMS who have not responded to treatment with interferons, or have rapidly evolving severe MS.

Novartis also announced new pooled analyses presented at the 66(th) American Academy of Neurology (AAN) Annual Meeting in Philadelphia, Pennsylvania from the pivotal FREEDOMS and FREEDOMS II trials in multiple sclerosis or MS, confirming the consistent efficacy of Gilenya across four key measures of MS (relapse rates, MRI lesions, brain volume loss and disability progression). Addressing these four measures through effective treatment and disease management is important for improving the course of MS for patients.

The pooled analyses from the FREEDOMS and FREEDOMS II trials show that in patients with high disease activity previously treated in the past year, Gilenya demonstrated significant efficacy across the certain measures.

Gilenya reduced relapses (as measured by the annualized relapse rate) by almost half (48%) compared to placebo; new T2 lesion formation was reduced by 69% compared to placebo; Gilenya reduced the rate of brain volume loss by 46% compared to placebo; using a stringent six-month disability measure, Gilenya reduced disability progression by 45% compared to placebo.

Source: RTT News Copyright © 2014 RTTNews (29/04/14)

Gilenya appears to have an effect on B-Cells in MS(18/02/14)

Differential effects of fingolimod on B-cell populations in multiple sclerosis

Abstract

BACKGROUND: Fingolimod is an oral drug approved for multiple sclerosis (MS) with an ability to trap central memory T cells in secondary lymphoid tissues; however, its variable effectiveness in individual patients indicates the need to evaluate its effects on other lymphoid cells.

OBJECTIVE: To clarify the effects of fingolimod on B-cell populations in patients with MS.

METHODS: We analysed blood samples from 9 fingolimod-treated and 19 control patients with MS by flow cytometry, to determine the frequencies and activation states of naive B cells, memory B cells, and plasmablasts.

RESULTS: The frequencies of each B-cell population in peripheral blood mononuclear cells (PBMC) were greatly reduced 2 weeks after starting fingolimod treatment. Detailed analysis revealed a significant reduction in activated memory B cells (CD38int-high), particularly those expressing Ki-67, a marker of cell proliferation. Also, we noted an increased proportion of activated plasmablasts (CD138+) among whole plasmablasts, in the patients treated with fingolimod.

CONCLUSIONS: The marked reduction of Ki-67+ memory B cells may be directly linked with the effectiveness of fingolimod in treating MS. In contrast, the relative resistance of CD138+ plasmablasts to fingolimod may be of relevance for understanding the differential effectiveness of fingolimod in individual patients.

Nakamura M, Matsuoka T, Chihara N, Miyake S, Sato W, Araki M, Okamoto T, Lin Y, Ogawa M, Murata M, Aranami T, Yamamura T.

Source: Mult Scler. 2014 Feb 13. & Pubmed PMID: 24526661 (18/02/14)

FDA continues to investigate possible MS drug Gilenya link to brain infection death(21/10/13)

The FDA is continuing to investigate a possible link between the multiple sclerosis drug Gilenya (fingolimod) and a case of a rare brain infection in a European patient.

The patient took the drug for nearly 8 months before being diagnosed with the brain infection. The FDA issued an alert at the end of August to inform the public of its investigation.

The brain infection, sometimes fatal, is called PML (progressive multifocal leukoencephalopathy). The European case is the first reported in a patient who has not previously taken the drug Tysabri (natalizumab). Tysabri is already known to be linked with a higher risk for PML.

The maker of Gilenya, Novartis, issued a statement saying it had reviewed all available evidence and that the case of PML in Europe is unlikely to be linked to the drug.

Gilenya, approved by the FDA in 2010 for relapsing MS, is taken by mouth. It is one of three new oral drugs approved in the last 3 years. The other two are Tecfidera (dimethyl fumarate) and Aubagio (teriflunomide).

In MS, the immune system attacks the central nervous system, including the brain, spinal cord, and optic nerves.

According to the FDA, patients should not quit taking Gilenya without talking to their doctor.

The FDA will issue its findings once the investigation is complete.

Source: WedMD ©2005-2013 WebMD, LLC. (21/10/13)

Gilenya® shown to reduce MS relapse rates compared to interferons or glatiramer acetate(03/10/13)

Novartis announced today findings from an international multiple sclerosis (MS) registry and a US health claims data base which showed the real-world superiority of Gilenya® (fingolimod) in reducing risks of relapses compared to standard therapies. These data confirm the positive results seen in clinical trials with Gilenya, and were presented at the ongoing 29th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Copenhagen, Denmark.

Relapses can make life unpredictable for patients with MS and they can potentially significantly advance an individual's level of disability. MS patients' clinical outcomes are regularly assessed and switching between disease-modifying therapies (DMTs), to reduce the rate or likelihood of a relapse, is a frequent treatment strategy.

"Controlling relapses and preventing disability are key treatment goals for patients with MS." said David Epstein, Division Head of Novartis Pharmaceuticals. "It is encouraging to see that the benefits of Gilenya, which is the only disease modifying treatment proven in clinical studies to have a superior relapse reduction compared to an active comparator, are now confirmed in the real-world setting."

The 'MSBase study', a global, longitudinal, observational registry for MS involving 60 centers in 26 countries and US administrative claims data from the 'IMS PharMetrics PlusTM Database' were interrogated for information on the impact on MS relapses of switching to either oral Gilenya or to one of the standard injectable therapies - an interferon or glatiramer acetate. Collectively, analysis of patient data from these large, real-world databases (416 patients from MSBase and 933 patients from the IMS PharMetrics PlusTM Database) showed that treatment with Gilenya reduced the annualized relapse rate and risk of relapse by approximately 50% compared to therapy with an interferon or glatiramer acetate treatment. They also showed that even amongst patients with MS who have a history of relapse, switching to Gilenya was associated with significant and clinically meaningful reductions in the number of relapses and the probability of experiencing a relapse compared to switching to an interferon or glatiramer acetate.

Following first approvals in 2010, once daily oral Gilenya is now available in more than 75 countries and more than 71,000 patients have been treated in both the clinical trial and post-marketing settings with over 87,000 patient years of exposure.

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

Novartis confirms long term benefits of Gilenya in multiple sclerosis(25/09/13)

Novartis International AG has announced that new data showing the benefits of Gilenya on patient outcomes in multiple sclerosis will be presented at the 29th Congress of the European Committee for Research and Treatment in Multiple Sclerosis in Copenhagen, Denmark.

Novartis said the new four-year data from the pivotal FREEDOMS and FREEDOMS extension studies plus a separate analysis of three studies (FREEDOMS, FREEDOMS II and TRANSFORMS) will show the benefits of continued Gilenya treatment on brain volume loss compared to delayed treatment of two years. The company said these data will reinforce the correlation between brain volume loss and disability, underlining the need for addressing brain volume loss in patients with Multiple Sclerosis.

Data from international and U.S. real-world databases will also confirm the favourable effect of Gilenya on reducing relapse rates for patients with Multiple Sclerosis, the company said.

Source: RTT News Copyright © 2013 RTTNews (25/09/13)