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Sanofi-Aventis Heart Drug Not Approved


Posted on 2006-08-31 14:36:00



French pharmaceutical company Sanofi-Aventis SA said Thursday it received a non-approvable letter from the U.S. Food and Drug Administration for dronedarone, a heart drug known by its trade name Multaq.

Sanofi said it expects to reapply for approval in the first half of 2008, with the results of an ongoing trial on the drug.

Non-approvable letters are issued to a drug's sponsor when the agency does not find adequate data in a company's marketing application to warrant approval.

Multaq is intended to treat atrial fibrillation, an irregular beating of the upper chambers of the heart that affects more than 2 million people in the U.S. alone.

The company said 4300 patients are to participate in the study, which aims to assess the drug's effectiveness in preventing heart-related hospitalizations or death from any cause.

The French drug maker, the world's third largest, also said a U.S. District Court in California has postponed a patent infringement trial involving its best-selling blood-thinner, Lovenox, until Dec. 4.


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