Novartis AG (NVS) has confirmed a positive benefit-risk profile of once-daily oral Gilenya following European Medicines Agency's Committee for Medicinal Products for Human Use or CHMP review and label update recommendation. Novartis and the CHMP have agreed to recommended updates to the product information in the European Union in order to provide further guidance to healthcare providers on treatment initiation with Gilenya in MS patients.
The CHMP labeling recommendations would be reviewed by the European Commission with a final decision expected in June 2012. The company would inform physicians in the European Union of the changes in the product information in the EU through a Direct Healthcare Provider Communication by April 2012 end.
For comments and feedback: editorial@rttnews.com