Novartis’ Gilenya (fingolimod) Receives EU’s Approval for Relapsing-Remitting Forms of Multiple Sclerosis (RRMS)

Shots:

• The approval is based on the results of P-III PARADIGMS study assessing Gilenya (0.5mg/ 0.25mg, qd) vs Extavia (interferon beta-1a, qw) in 215 patients with MS aged 10 to <18 yrs, across 80 centers and 25 countries
• P-III PARADIGMS study Results: annualized relapse rates by 82%; relapse-free @ 24 months (85.7% vs 38.8%); reduction of disability progression 77%; reduction in no. of T2 lesions 53%; annualized rate of brain volume loss 40%
• Gilenya is a S1P modulator, approved to treat relapsing forms of multiple sclerosis and is available in the US, EU including Iceland, Norway and Liechtenstein

Click here to read full press release/ article | Ref: Novartis | Image: The Business Journals