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EMA, FDA update Gilenya label

April 21, 2012 12:01 AM UTC

EMA and FDA updated the label for Gilenya fingolimod from Novartis AG (NYSE:NVS; SIX:NOVN) on Friday to include new cardiovascular-related warnings and recommendations for the multiple sclerosis (MS) drug. Following a safety review, EMA's CHMP said physicians should not prescribe the drug to patients with a history of cardiovascular and cerebrovascular disease or who take heart-rate lowering medication. When Gilenya is considered necessary in these patients, CHMP said heart rate activity should be monitored at least overnight following the first dose and physicians should seek advice from a cardiologist on appropriate monitoring. FDA said patients with pre-existing cardiac conditions or taking concomitant anti-arrhythmic drugs who initiate treatment with Gilenya require overnight monitoring. ...