Novartis Receives European Commission Approval For Gilenya(R), The First Oral Multiple Sclerosis Treatment For Use In The EU

“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.”

The approval was based on the largest clinical trial program submitted to date for a new MS drug, and 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 (MRI), a measure of disease activity1,2

“Today’s announcement marks another major regulatory approval and we are pleased that Gilenya will become available to more eligible MS patients,” said David Epstein, Division Head of Novartis Pharmaceuticals. “Novartis is dedicated to bringing innovative new treatments to patients where there is significant unmet need. Gilenya has been in clinical development for MS since 2003 and we are grateful for the commitment of those involved, especially the trial participants, who have contributed significantly to the development of this novel medicine.”