Novartis Gains EU Approval for Gilenya

Novartis received approval from the European Commission for Gilenya (fingolimod) 0.5 mg daily pill for the treatment of highly active relapsing-remitting multiple sclerosis (RRMS), or in patients with rapidly evolving severe RRMS.

The EU application included data showing significant efficacy in reducing relapses, the risk of disability progression, and the number of brain lesions detected by magnetic resonance imaging (MRI).

“This 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.”

Gilenya, licensed from Mitsubishi Tanabe Pharma, is the first in a new class of drugs called sphingosine 1-phosphate receptor (S1PR) modulators. Gilenya is thought to work by reducing the immune system’s attack on the central nervous system (CNS) by retaining certain white blood cells (lymphocytes) in the lymph nodes, preventing them from reaching the CNS and attacking it.