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22 Mar 2011

Novartis Gains EU Approval for Gilenya

Novartis received approval from the European Commission for Gilenya. The approval will make the treatment available to more eligible MS patients.

Novartis received approval from the European Commission for Gilenya (fingolimod) 0.5 mg daily pill,  a 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).

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

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