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Published on 19 March 2009

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Panel backs heart condition drug

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Patients suffering with irregular heart rhythms linked to stroke could soon be treated with a new medicine after experts recommended it for approval by the US drugs watchdog.

The US Food and Drug Administration’s (FDA’s) cardiology drug panel put Multaq forward as a treatment for atrial fibrillation.

The condition interferes with the contractions of the heart’s upper chambers and is related to about 15% of strokes, according to the American Heart Association.

The FDA is expected to make a final decision on the drug by April 30 and, though it is not required to follow the group’s advice, it usually does. If approved, it would be the first new treatment for atrial fibrillation in more than a quarter of a century.

A statement from the drug’s maker, Sanofi, said: “The panel’s insightful feedback which concluded with a positive vote is an important step in gaining FDA approval.”

The positive recommendation marks a comeback from Multaq, which was rejected by FDA in 2006 after a study linked the medication to higher death rates.

But more recent trials showed that Multaq significantly reduced the need for patients to be sent to hospital with atrial fibrillation when compared with a placebo.

Copyright Press Association 2009

FDA



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