Sanofi-Aventis heart drug approved

By Associated Press  |  July 3, 2009

NEW YORK - Sanofi-Aventis SA said its drug Multaq, which treats irregular heart rhythms, received marketing approval after a delay of nearly three years.

Multaq is intended to treat atrial flutter and atrial fibrillation, a disease in which the upper chambers of the heart do not beat regularly, which can cause strokes and death. Sanofi-Aventis said Multaq is the first drug for atrial fibrillation that has been shown to reduce hospitalization due to cardiovascular problems.

Atrial flutter can develop into atrial fibrillation.

Multaq, or dronedarone, will be sold in 400-milligram tablets intended to be taken twice per day. Sanofi-Aventis plans to launch the drug this summer. The company estimates there are 2.5 million atrial fibrillation patients in the United States, and another 4.5 million in the European Union, where it is also seeking marketing approval.

In August 2006, the Food and Drug Administration told the French drug maker that its marketing application did not contain enough data for approval. Since then, Sanofi-Aventis completed two major studies of Multaq. One showed it helped reduce hospitalization and death from heart-related problems by 24 percent, and the other showed it lowered the risk of both ischemic and hemorrhagic stroke by 34 percent. Both were significantly better than a placebo.

An FDA cardiology panel recommended in March that the drug be approved.

Shares of Sanofi-Aventis fell 64 cents to close at $29.70, following the disclosure of an FDA review on the safety of the company’s synthetic insulin, Lantus.