Novartis gains positive CHMP opinion for Gilenya, oral multiple sclerosis treatment
Two-year, placebo-controlled study demonstrated that Gilenya significantly reduced the risk of disability progression
The CHMP opinion was based on the largest clinical trial program submitted to date for a new MS drug, and included data from clinical studies showing significant efficacy in reducing relapses, the risk of disability progression, and the number of brain lesions detected by magnetic resonance imaging (MRI), a measure of disease activity.
"More than 500,000 people in the EU live with MS, a debilitating neurological condition that involves an unpredictable, life-long progression of complex symptoms," commented John Golding, President, European Multiple Sclerosis Platform (EMSP). "The first available oral MS treatment that offers significant efficacy for appropriate patients is a welcome alternative."
The CHMP recommendation forms the basis for a European Commission licensing decision, which is expected in approximately three months.
Most read news
Other news from the department research and development
Get the life science industry in your inbox
From now on, don't miss a thing: Our newsletter for biotechnology, pharma and life sciences brings you up to date every Tuesday and Thursday. The latest industry news, product highlights and innovations - compact and easy to understand in your inbox. Researched by us so you don't have to.