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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).

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By: Tim Wright

Editor-in-Chief, Contract Pharma

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 ...

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