Novartis confirms growing Gilenya® clinical and real-world experience as number of patients treated increases to over 63,000

Latest global patient-use data show that Gilenya® (fingolimod) has been used to treat more than 63,000 patients in clinical trials and the post-marketing setting[1].

“As the first once-daily oral MS therapy, we are pleased Gilenya has played such an important role in addressing unmet medical need in the MS community in the two years following initial approvals,” said David Epstein, Head of the Pharmaceuticals Division of Novartis Pharma AG. “Our growing experience reinforces Gilenya’s high efficacy and very good tolerability profile and Novartis remains committed to ensuring eligible patients have access to Gilenya.”

Gilenya is the only approved treatment shown to consistently decrease brain volume loss[2],[3]. Brain volume loss is the best magnetic resonance imaging (MRI) correlate of long-term disability. New data presented at the recent 65th Annual Meeting American Academy of Neurology (AAN), showed that Gilenya reduced the rate of brain volume loss by about one-third compared to interferon beta-1a IM or placebo in studies with over 3,600 patients with relapsing MS.[4] Patients from a Phase II study who remained on treatment for up to seven years experienced consistently low rates of brain volume loss[5].

Data has also shown significant efficacy with Gilenya in reducing relapses and slowing of six-month disability progression sustained at four years[6]. Nearly half of Gilenya patients were disease-free after one year of treatment[7],[8] and in the pivotal FREEDOMS study, eight out of ten patients on the approved dose remained on treatment at two years[2].

In clinical trials Gilenya exhibited a well-characterized safety profile and very good tolerability profile[2],[3].

Gilenya was approved based on the largest phase III clinical trial program in MS at the time of submission, which included a head-to-head study versus Avonex® (interferon beta-1a IM), a commonly prescribed treatment. Gilenya is now approved in 70 countries, and there is approximately 73,000 patient years of exposure[1].

Up to 2.5 million people worldwide are affected with MS[9], a neurodegenerative condition that often begins in early adulthood[10]. Around 70% of newly diagnosed patients with MS are in the prime of their lives – between 20 and 40 years of age – so most people are employed at the time of diagnosis. This can have a significant impact on careers, quality of life and families[11],[12].

About Gilenya

Gilenya is the first oral therapy approved to treat relapsing forms of MS and the first in a new class of compounds called sphingosine 1-phosphate receptor (S1PR) modulators. Gilenya is thought to act on inflammatory processes implicated in the MS disease process[13],[14].

Gilenya has demonstrated superior efficacy compared to Avonex® (interferon beta-1a IM), a commonly prescribed treatment, showing a 52% relative reduction in annualized relapse rate (primary endpoint) at one year in a pivotal head-to-head trial in patients with relapsing-remitting multiple sclerosis[3]. In a post hoc sub-group analysis, Gilenya showed a 61% relative reduction in annualized relapse rate compared to interferon-beta-1a IM at one year in subgroups of patients with highly active relapsing-remitting MS not responding to interferon treatment[15].

In clinical trials Gilenya exhibited a well-characterized safety profile and very good tolerability profile[2],[3]. The most common side effects were headache, liver enzyme elevations, influenza, diarrhea, back pain, and cough. Other Gilenya-related side effects included transient, generally asymptomatic, heart rate reduction and atrioventricular block upon treatment initiation, mild blood pressure increase, macular edema, and mild bronchoconstriction[2],[3]. The rates of infections overall, including serious infections, were comparable among treatment groups, although a slight increase in lower respiratory tract infections (primarily bronchitis) was seen in patients treated with Gilenya. The number of malignancies reported across the clinical trial program was small, with comparable rates between the Gilenya and control groups[2],[3].

Gilenya is licensed from Mitsubishi Tanabe Pharma Corporation.

References:

1. Data on file. Novartis Pharma AG.
2. Kappos L. et al; for FREEDOMS Study Group. A placebo-controlled trial of oral fingolimod in relapsing multiple sclerosis. N Engl J Med. 2010;362(5):387-401.
3. Cohen JA, Barkhof F, Comi G, et al; for TRANSFORMS Study Group. Oral fingolimod or intramuscular interferon for relapsing multiple sclerosis. N Engl J Med. 2010;362(5):402-415
4. Cohen J. et al. Fingolimod-effect on brain atrophy and clinical/MRI correlations in Three Phase 3 studies – TRANSFORMS, FREEDOMS and FREEDOMS II. Abstract Presented at AAN, San Diego, March 2013.
5. Chin PS, Calabresi PA, Zhang Y, von Rosenstiel P, Kappos L. Early effect of fingolimod on clinical and MRI related outcomes in relapsing multiple sclerosis. Poster presented at: 28th Congress of the European Committee for Treatment and Research in Multiple Sclerosis; October 10-13, 2012: Lyon, France. Abstract P459
6. Kappos L. et al. Phase 3 FREEDOMS study extension: fingolimod (FTY720) efficacy in patients with relapsing-remitting multiple sclerosis receiving continuous or placebo-fingolimod switched therapy for up to 4 years. Poster presented at: 28th Congress of the European Committee for Treatment and Research in Multiple Sclerosis; October 10-13, 2012: Lyon, France. Poster P979.
7. Khatri B. et al. Fingolimod treatment increases the proportion of patients who are free from disease activity in multiple sclerosis compared to interferon beta-1a: results from a phase 3 activecontrolled study (TRANSFORMS). Abstract presented at: 64th AAN Annual Meeting; April 21-28, 2012; New Orleans, LA. Abstract PD5:006.
8. Khatri B. et al. Fingolimod treatment increases the proportion of patients who are free from disease activity in multiple sclerosis compared to interferon beta-1a: results from a phase 3 active-controlled study (TRANSFORMS). Poster presented at: 64th AAN Annual Meeting; April 21-28, 2012; New Orleans, LA. Poster PD5:006.
9. Multiple Sclerosis International Federation. Atlas of MS [online]. Available at: www.atlasofms.org. Accessed January 2013.
10. Declaration of the European Parliament of 13 September 2012 on tackling multiple sclerosis in Europe http://www.europarl.europa.eu/sides/getDoc.do?type=TA&reference=P7-TA-2012-0357&format=XML&language=EN. Accessed January 2013.
11. European Multiple Sclerosis Platform, MS fact sheet 2011 http://www.ms-in-europe.org/multiple-sclerosis/index.php?kategorie=whatisms&cnr=6&anr=127. Accessed January 2013.
12. Multiple Sclerosis Factsheet http://www.emsp.org/ms-need/content/factsheet.pdf Accessed January 2013.
13. Brinkmann V. FTY720 (fingolimod) in multiple sclerosis: therapeutic effects in the immune and the central nervous system. Br J Pharmacol 2009;158(5):1173-1182.
14. Chun J, Hartung HP. Mechanism of Action of Oral Fingolimod (FTY720) in Multiple Sclerosis. Clin Neuropharmacol. 2010 Mar-Apr;33(2):91-101.
15. Havrdová E. et al. Clinical outcomes in subgroups of patients with highly action relapsing-remitting multiple sclerosis treated with Fingolimod (FTY720): Results from the FREEDOMS and TRANSFORMS phase III studies. Poster presented at ECTRIMS, Amsterdam, October 2011.

Avonex® is a registered trademark of Biogen Idec.