Basel, January 24, 2011 – Swissmedic, the Swiss Agency for Therapeutic Products, and the Australian Therapeutic Goods Administration (TGA) have granted approval for Gilenya® (fingolimod) 0.5mg as a first-line, oral disease-modifying therapy (DMT) for the treatment of relapsing-remitting multiple sclerosis (RRMS).
“Gilenya, with its innovative mechanism of action, can improve clinical outcomes in patients with relapsing remitting MS,” said Professor Ludwig Kappos, Neurology and Department of Research, University Hospital, Basel, Switzerland.
“The significant efficacy and manageable safety profile of Gilenya make it a valuable new option for patients with relapsing-remitting MS and the physicians who treat them.”
The Gilenya approvals were based on the largest clinical trial program conducted in MSto date.
The application included data showing Gilenya 0.5mg reduced relapses by 52% (P<0.001) at one year compared with interferon beta-1a IM, an approved first-line DMT.
Data from a two-year placebo-controlled study showed a reduction in relapse rate of 54% (P<0.001) compared with placebo.
In the same study, patients on Gilenya 0.5mg had a 30% lower risk of disability progression, confirmed after three months and a 37% lower risk of disability progression, confirmed after six months.
The studies also showed that treatment with Gilenya resulted in statistically significant reductions in brain lesion activity as measured by magnetic resonance imaging.
“Following the approval of Gilenya in the United States and in Russia, we are proud that we can now offer this effective, once-daily oral treatment to patients in Switzerland and Australia,” said David Epstein, Division Head of Novartis Pharmaceuticals.
“Novartis has an excellent track record of securing access to innovative medicines for patients and we are committed to assuring access to Gilenya for eligible patients around the world.”
Gilenya, licensed from Mitsubishi Tanabe Pharma Corporation, is the first in a new class of compounds called sphingosine 1-phosphate receptor (S1PR) modulators.
Gilenya provides selective and reversible retention of lymphocytes in lymph nodes, which helps preserve key immune functions and provides flexibility in patient management.
Gilenya has been studied in more than 4,000 MS patients.
The most common side effects are headache, liver enzyme elevations, influenza, diarrhea, back pain, and cough.
Other Gilenya-related side effects include transient, generally asymptomatic, heart rate reduction and atrioventricular block upon treatment initiation, mild blood pressure increase, macular edema, and mild bronchoconstriction.
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 Gilenya-treated patients.
The number of malignancies reported across the clinical trial program was small, with comparable rates between the Gilenya and control groups.
Multiple Sclerosis can cause a range of physical and mental problems including loss of muscle control and strength, vision, balance, sensation and mental function.
Over time, with repeated attacks, damage accumulates leading to permanent nerve damage and loss of neurological function.
It is estimated that MS affects up to 2.5m people worldwide and is potentially the most common cause of non-traumatic, neurological disability in young adults.
Novartis has filed Gilenya with health authorities worldwide.