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ARTICLE | Clinical News

Novartis' Gilenya meets in Phase III for pediatric MS

September 29, 2017 9:25 PM UTC

Novartis AG (NYSE:NVS; SIX:NOVN) reported top-line data from the Phase III PARADIGMS trial in 215 patients ages 10-17 with multiple sclerosis showing that once-daily oral Gilenya (Imusera) fingolimod (FTY720) met the primary endpoint of reducing annualized relapse rate (ARR) over 2 years vs. once-weekly intramuscular Avonex interferon beta-1a. Novartis said it plans to review the data and speak with health authorities to discuss next steps for the pediatric indication.

Secondary endpoints in the double-blind, placebo-controlled, international trial include the number of new or newly enlarged T2 lesions, gadolinium-enhancing T1 lesions, safety and pharmacokinetics. The trial also includes a 5-year, open-label extension. Data from PARADIGMS will be presented at the Joint ECTRIMS-ACTRIMS meeting in Paris this month...