Novartis Updates Label For Multiple Sclerosis Drug

Novartis AG April 20 announced an agreement with the Food and Drug Administration to update the label of the multiple sclerosis (MS) drug Gilenya (fingolimod).

Gilenya was approved in 2010 to reduce relapses and delay disability progression in patients with relapsing forms of MS. It has several known side effects, including a decrease in heart rate or atrioventricular conduction, or both, after the first dose, according to FDA.

The update to the Gilenya prescribing information includes patient selection parameters to aid in the identification of candidates for Gilenya treatment and more specific recommendations for treatment initiation for patients with relapsing ...