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MS Pill Gilenya® (Fingolimod) Shows Significant Early Effect On Reducing Brain Volume Loss At Six Months, New Analysis Indicates

Early effects on MRI lesions, brain atrophy and relapses replicated across two large Phase III trials suggest substantial early treatment benefits of 1. Pooled analysis of core and long-term study data from over 3,500 patients reinforces known of ; more than 49,000 patients treated worldwide2,3. New data show generally higher adherence rates for once-daily pill than injectable DMTs and positive real-world experience4,5

Extensive new data presented at the 28th congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) reinforces the generally early and sustained efficacy benefit and long-term safety profile of Gilenya® (fingolimod), the first once-daily oral therapy approved to treat highly active relapsing-remitting multiple sclerosis (RRMS). The new data add to the growing body of evidence for fingolimod regarding early efficacy benefits, consistent long-term safety profile and positive real-world experience.

Efficacy: New analysis shows significant early with fingolimod

A new post hoc analysis of two large Phase III studies ( and II) showed that treatment with fingolimod 0.5 mg led to significant benefits on loss and -related outcomes compared to placebo within the first six months.1 The authors of the analysis noted, “The expected time lag between start of treatment and onset of efficacy is an important consideration for MS therapy, as early benefits may prevent excess morbidity.”1

With regard to brain volume loss, in the FREEDOMS study, patients treated with fingolimod 0.5 mg had on average, a 35% reduction in brain volume loss compared with placebo at the first MRI scan after six months of treatment (mean percent brain volume change of -0.22 for fingolimod vs. -0.34 for placebo; p=0.006).1 In the FREEDOMS II study, there was a 39% reduction in brain volume loss (mean percent volume change of -0.23 for fingolimod vs. -0.38 for placebo; p=0.012) at six months.1

Loss of brain volume (also known as brain atrophy) is a characteristic feature of disease progression in patients with MS. Minimising brain volume loss is therefore an important clinical parameter.

With regards to relapse-related outcomes, in the FREEDOMS study, patients treated with fingolimod 0.5 mg had a 39% reduction in time to first confirmed relapse compared to placebo after six months (estimated percent of patients free of confirmed MS relapse was 86.5 for fingolimod vs. 77.9 for placebo). In FREEDOMS II, there was a 46% reduction in time to first confirmed relapse compared to placebo at six months (estimated percent of patients free of confirmed MS relapse was 87.4 for fingolimod vs. 77.9 for placebo). Treatment effects in delaying time to first confirmed MS relapse (p<0.05) were observed as early as day 82 in FREEDOMS and day 64 in FREEDOMS II.1

“Understanding the onset of efficacy is an important consideration in the treatment of MS as early effective treatment may improve patient outcomes,” said Professor Ludwig Kappos, MD, Chair of Neurology, University Hospital, Basel, Switzerland and lead author of the Phase III FREEDOMS trial on fingolimod. “The new analysis of Phase III data shows a significant early effect of fingolimod on relapses and MRI measures and further supports its role as a valuable treatment option for relapsing-remitting MS.”

Safety: Results from > 3,500 patients further characterise long-term safety profile of fingolimod

A new integrated analysis of safety data from Phase II, Phase III and study extensions for fingolimod (all doses, n=3553) show a safety profile generally consistent with previous results. The total fingolimod exposure was 9,070 patient years, with 1,510 patients treated for more than three years and some for more than seven years.2 As of August 2012, more than 49,000 patients had been treated with fingolimod worldwide.3

Real-world experience: New data demonstrate positive real-world experience and patient adherence with fingolimod

First results from the PANGAEA observational study in Germany indicate that 90% of investigators and 91% of patients rated fingolimod treatment success, defined as efficacy and tolerability, as “Good” or “Very Good”4. PANGAEA is a German registry study aimed to enroll a total of 4,000 patients with a follow-up of five years designed to investigate the efficacy and safety of fingolimod in everyday clinical practice. As of May 2012, one year after initiation of the registry, more than 1,850 patients were enrolled in 475 participating centres. These results also showed an overall safety profile in line with previously reported data.4

In addition, a separate analysis of time to discontinuation of therapy among MS patients receiving fingolimod and other disease modifying treatments (DMTs) using pharmacy claims in the US (n=1891) show fingolimod-treated patients were not only significantly less likely to discontinue treatment over the 12 month observation period (fingolimod: 27.8%, other DMT cohorts: 42.7-54.5%; p<0.01) but also discontinued later than patients using injectable DMTs.5

Novartis MS pipeline

The data presented at ECTRIMS underscores the depth and breadth of the Novartis MS portfolio and ongoing commitment to addressing unmet patient needs in MS. Alongside the extensive new data reinforcing the efficacy and safety profile of once-daily oral fingolimod, new data was presented on investigational compound BAF312 (siponimod) from the Phase II BOLD study in RRMS.

Additional information on fingolimod

  • Fingolimod is an effective once-daily oral MS treatment without label restrictions specific to treatment duration, making it a valuable option for appropriate people with highly active RRMS and the neurologists who treat them6,7
  • Fingolimod addresses an unmet clinical need and a significant gap in funded treatment options for patients with highly active RRMS who continue to relapse despite treatment with an interferon therapy8
  • There is increasing experience of fingolimod’s long-term effectiveness and safety profile, and approximately 49,000 patients have received the drug worldwide to date3
  • Fingolimod has been approved in more than 60 countries. In the EU, fingolimod has been launched and reimbursed in a number of markets, including Germany, France, Denmark, Sweden, Norway, Austria, Greece, Italy, Spain, Belgium, Portugal and the Netherlands. Fingolimod also has been launched and reimbursed in other key markets including the United States, Canada, Australia and Switzerland.

Source

1. Chin P.S. et al. Early effect of fingolimod on clinical and MRI related outcomes in relapsing multiple sclerosis. Abstract Presented at ECTRIMS, Lyon, France, October 2012.

2. Cohen J. et al. Long-term safety of fingolimod in relapsing multiple sclerosis: update to integrated analyses of phase 2 and 3 studies and extension phases. Abstract Presented at ECTRIMS, Lyon, France, October 2012.

3. Novartis data on file.

4. Ziemssen T. et al. Study design and first interim results of a registry study to establish long-term safety and pharmaco-economic data on fingolimod (Gilenya®) in multiple sclerosis patients in Germany (PANGAEA). Abstract Presented at ECTRIMS, Lyon, France, October 2012.

5. Neetu A. et al. Comparison of Time to Discontinuation Among Multiple Sclerosis Patients Receiving Fingolimod and Other First-Line Disease Modifying Treatments. Abstract Presented at ECTRIMS, Lyon, France, October 2012.

6. Cohen JA et al. Oral Fingolimod vs. intramuscular interferon in relapsing multiple sclerosis. N Eng J Med2010, 362 (5) 405-415.

7. Kappos L et al. Placebo-controlled study of oral fingolimod in relapsing multiple sclerosis. N Eng J Med 2010, 362 (5) 387-401.

8. SMC assessment of fingolimod (as hydrochloride), 0.5mg hard capsules (Gilenya). 10 September 2012.

9. Gilenya Summary of Product Characteristics. 2012. http://www.medicines.org.uk/EMC/medicine/24443/SPC/Gilenya+0.5mg+hard+capsules. Last accessed 30 August 2012.

10.Novartis data on file. 2012.

11.O’Connor P et al. Oral fingolimod (FTY720) in MS. Two-year results of a phase II extension study. Neurology. 2009, 72; 73-79.

Source: Novartis