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News & Analysis US

Novartis Receives EU Approval For Multiple Sclerosis Drug Gilenya - Update

March 21, 2011, Monday, 04:21 GMT | 00:21 EST | 08:51 IST | 11:21 SGT

(RTTNews) - Swiss healthcare giant Novartis AG (NVS) Monday said the European Commission approved Gilenya, which would be the first oral multiple sclerosis treatment for use in the EU.

The Gilenya (fingolimod) 0.5 mg daily could be used as a disease modifying therapy in patients with highly active relapsing-remitting multiple sclerosis or RRMS despite treatment with beta interferon, or in patients with rapidly evolving severe RRMS.

Gilenya, licensed from Mitsubishi Tanabe Pharma Corp., is the first in a new class of drugs called sphingosine 1-phosphate receptor or S1PR modulators.

According to Hans-Peter Hartung, Professor and Chairman, Dept. of Neurology, Heinrich-Heine University, Germany, Gilenya is the first approved therapy for MS that offers significant efficacy in a capsule.

The EU approval was based on the two-year, placebo-controlled study, which was the largest clinical trial program submitted to date for a new MS drug. The study demonstrated that Gilenya significantly reduced the risk of disability progression.

The approval included data from clinical studies showing significant efficacy in reducing relapses, the risk of disability progression, and the number of brain lesions detected by magnetic resonance imaging or MRI, a measure of disease activity.

Novartis noted that Gilenya, which has been in clinical development for MS since 2003, showed superior efficacy to interferon beta-1a IM, a commonly prescribed treatment, reducing relapses by 52% at one year. In clinical studies, treatment with Gilenya also resulted in statistically significant reductions in brain lesion activity as measured by MRI.

David Epstein, Division Head of Novartis Pharmaceuticals, stated, "Today's announcement marks another major regulatory approval and we are pleased that Gilenya will become available to more eligible MS patients."

Gilenya has been studied in more than 4000 MS patients. The drug's common side effects are headache, liver enzyme elevations, influenza, diarrhea, back pain, and cough.

NVS closed Friday's regular trading at $53.69, down $0.10 or 0.19%, on a volume of 4 million shares.