Reuters: Regulatory News: EU supports Novartis MS pill with stronger warning

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EU supports Novartis MS pill with stronger warning Apr 20th 2012, 09:14 LONDON, April 20 | Fri Apr 20, 2012 5:14am EDT LONDON, April 20 (Reuters) - European regulators endorsed the continued use of Novartis AG's multiple sclerosis pill Gilenya, one of the Swiss firm's top new drug hopes, but said on Friday the drug needed to carry stronger warnings on heart risks. The European Medicines Agency (EMA), which had initially aimed to give an update on the medicine last month, said doctors should not prescribe Gilenya to patients with a history of cardiovascular and cerebrovascular disease or those on heart-rate lowering medication. If treatment with Gilenya was considered necessary in these patients, however, their heart activity should be monitored at least overnight following the first dose of the drug. Prospects for Gilenya have been clouded by concern about its association with serious heart problems. Gilenya, the first multiple sclerosis (MS) pill of its kind, is seen by analysts as a potential blockbuster with annual sales of $1.7 billion by 2015, according to consensus forecasts collected by Thomson Reuters Pharma. That is down on the $2.2 billion seen at the end of 2011 as doctors have grown more cautious about the drug following reports of heart problems in some patients and the death of one person in the United States within 24 hours of starting treatment.

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