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FDA Concludes Safety Review Of Novartis MS Drug Gilenya

05/14/2012 | 12:55pm US/Eastern

--FDA concludes safety review of MS drug Gilenya

--FDA advises against use in certain heart and stroke patients

--FDA says no clear link between Gilenya and cardiovascular deaths

(Updates with additional background on EMA review starting in seventh paragraph and information on experimental Biogen Idec MS drug.)

   By Jennifer Corbett Dooren 

The U.S. Food and Drug Administration Monday said Novartis AG's (NVS, NOVN.VX) multiple-sclerosis drug Gilenya shouldn't be used in patients with a recent history of stroke or some types of heart problems, concluding a safety review of the drug.

The safety review was prompted by a report last November of a 59-year-old patient dying in the U.S. less than 24 hours after taking the first dose of the drug.

The agency said it continues to recommend that doctors closely monitor the hearts of patients after they have been given the first dose of the drug because the product can lower a person's heart rate temporarily.

As for the patient's death, the FDA said an exact cause of death couldn't be identified. The FDA said the patient had extensive brainstem MS lesions, which also have been associated with sudden death. The FDA also said it looked at other deaths that appeared to be from cardiovascular causes in patients who had been taking Gilenya and concluded that the drug's "contribution to the death was unclear."

The FDA said the drug shouldn't be used in patients who have had a stroke or heart trouble within the past six months. The agency also said the drug shouldn't be used in patients taking some kinds of antiarrhythmic heart medicines.

Europe's drug regulator, the European Medicines Agency, last month requested stronger safety warnings for Gilenya after the agency concluded its review of the drug.

Gilenya is currently the only oral MS drug on the market but its sales prospects have been clouded by recent safety concerns. It was approved in the U.S. in 2010 and has been available in Europe since 2011.

The product is designed to treat patients with the relapsing form of MS, which is a progressive disease that involves damage to the nerves controlling muscles and vision.

The FDA is currently reviewing another oral MS drug from Biogen Idec Inc. (BIIB) called BG-12 that is designed to work through a different mechanism than Gilenya. Biogen Idec last week announced that the FDA accepted BG-12's new drug application for a standard 10-month review, which sets an agency decision deadline of about Dec. 28.

-By Jennifer Corbett Dooren; Dow Jones Newswires, 202-862-9294;

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