Novartis reports final Phase III data of Gilenya in pediatric MS

Novartis AG (NYSE:NVS; SIX:NOVN) reported final 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) reduced annualized relapse rate (ARR) over 2 years, the primary endpoint, by 82% vs. once-weekly intramuscular Avonex interferon beta-1a. Novartis previously reported that Gilenya met the primary endpoint (see BioCentury, Sept. 29).

Gilenya also met the secondary endpoints of reducing the number of new or newly enlarged T2 lesions and gadolinium-enhancing T1 lesions vs. Avonex. Additionally, patients treated with Gilenya had significantly less brain volume loss as measured by MRI vs. Avonex. Furthermore, Gilenya significantly delayed disability progression vs. Avonex...