Basel – The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Gilenya® (fingolimod) 0.5mg daily as a disease modifying therapy in patients with highly active relapsing-remitting multiple sclerosis (MS) despite treatment with beta interferon, or in patients with rapidly evolving severe relapsing-remitting MS.
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.
“We’re pleased with today’s recommendation by the CHMP because it means patients in Europe with highly active relapsing-remitting MS could soon benefit from Gilenya’s significant efficacy in a once-daily capsule,” said David Epstein, Division Head of Novartis Pharmaceuticals.
“Novartis is committed to providing innovative medicines like Gilenya to patients with multiple sclerosis, and we look forward to working with countries across Europe towards this goal.”