Quoted from http://www.marketwatch.com/story/eu-to-rule-on-safety-of-novartiss-gilenya-ms-pill-2012-04-18
EU to rule on safety of Novartis's Gilenya MS pillBy Marta Falconi
April 19, 2012
ZURICH (MarketWatch) -- Europe's drug regulator will likely allow Novartis AG's Gilenya to stay on the market without asking for much stricter safety warnings as it concludes a review of the multiple sclerosis pill initiated after reports of heart problems and the death of a patient who took the drug.
The regulator's decision could come as early as Thursday, said the London-based European Medicines Agency, the body responsible for licensing Gilenya in Europe a year ago.
The EMA launched the in-depth study in January to assess Gilenya's benefits and risks, and recommended doctors closely monitor the hearts of patients after they have been given the first dose of the drug.
The review was prompted by reports of heart problems in patients taking Gilenya, as well as the November death of a 59-year-old patient in the U.S. less than 24 hours after taking the first dose of the drug. The EMA had aimed to give an update on Gilenya's safety in March, but delayed its decision by about a month as it finalizes its review.
The U.S. Food and Drug Administration also announced a safety review of Gilenya in December, saying there wasn't a clear cause of the patient's death. There is no time frame for the FDA's review.
[Article continues at original source]