Novartis receives European Commission approval for Gilenya®, the first oral multiple sclerosis treatment for use in the EU
The European Commission has granted Novartis approval for Gilenya® (fingolimod) 0.5 mg daily as a disease modifying therapy in patients with highly active relapsing-remitting multiple sclerosis (RRMS) despite treatment with beta interferon, or in patients with rapidly evolving severe RRMS.
- (1888PressRelease) March 21, 2011 - "Today marks an important step forward in the way we manage this chronic, debilitating disease in Europe," said Professor 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, which for many patients will come as a welcome additional option."
* Gilenya approved in the EU for people with highly active relapsing-remitting multiple sclerosis (RRMS) despite treatment with beta interferon, or in patients with rapidly evolving severe RRMS
* Gilenya showed superior efficacy to interferon beta-1a IM, a commonly prescribed treatment, reducing relapses by 52% (p
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