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

Ref: Novartis | Image: The Business Journals