LONDON, Jan 20 (Reuters) - The European Medicines Agency said on Friday it had begun a review
of the benefits and risks of Novartis's multiple sclerosis drug Gilenya, due to concern over the effects of the medicine on the heart after the first dose.
The move came after reports of heart problems in patients and the death of one person in the United States within 24 hours of starting treatment.
The Swiss drugmaker said last month it was investigating whether Gilenya, seen by analysts as a potential multibillion-dollar seller, caused the death of the 59-year-old U.S. patient.
Gilenya can temporarily slow the heart rate. Although this usually returns to normal after a few hours, the European watchdog said it was advising doctors to intensify cardiovascular monitoring after the first dose.
The U.S. Food and Drug Administration said on Dec. 20 it was also looking into the U.S. case. Regulators on both sides of the Atlantic said the exact cause of the patient's death was still unexplained.
European authorities approved Gilenya last March for people with highly active relapsing-remitting multiple sclerosis (RRMS), the commonest form of the debilitating disease.
More than 30,000 people have received the drug worldwide.
(Reporting by Ben Hirschler; Editing by Kate Kelland and Dan Lalor) Keywords: NOVARTIS/GILENYA
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