EMA confirms positive benefit-risk profile for Novartis' Gilenya, but with label change; updated US label

Swiss drug major Novartis (NOVN: VX) said on Friday that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has confirmed a positive benefit-risk profile of its once-daily oral multiple sclerosis drug Gilenya (fingolimod).

Novartis and the CHMP have agreed to recommended updates to the product information in the European Union in order to provide further guidance to health care providers regarding treatment initiation with Gilenya in MS patients. The changes follow the Article 20 review by the EMA announced in January 2012.

"We believe that Gilenya is a valuable treatment option for many patients with relapsing remitting MS, and we welcome the confirmation of the positive benefit-risk profile of the drug which also supports our continued belief of the blockbuster potential of Gilenya," said David Epstein, division head of Novartis Pharmaceuticals, adding: "MS is a devastating chronic disease that affects more than 2.1 million people worldwide, and patients need effective treatment options."