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FDA Offers Rapid Review for Sanofi/Bristol Heart Drug

Posted on: Thursday, 19 January 2006, 15:00 CST

The blockbuster drug Plavix could gain a new indication following the FDA's acceptance of an application by producers Sanofi-Aventis and Bristol-Myers Squibb who are seeking approval for the blood thinner as a treatment for heart attack.

The supplemental new drug application for Plavix (clopidogrel bisulfate) is designed to allow the product to be used for the treatment of a type of heart attack called ST-segment elevation myocardial infarction (STEMI), where prolonged blockage to the arteries causes heart muscle damage. Sanofi believes one-third of all heart attacks in the US are of this kind.

The companies have also submitted a filing to the European medicines evaluation agency (EMEA) for a STEMI indication in Europe.

The drug has been granted fast track status by the FDA which means the agency will aim to consider the drug application more swiftly than for products without this designation. It's believed the review will finish in May 2006. If successful the massive sales already achieved could be increased even further; during the first nine months of 2005 Bristol-Myers took $2.8 billion in Plavix sales alone.

Already the top-selling drug for both companies Plavix's success is set to continue. Last year Plavix sales increased by over 20% for Sanofi compared to the previous year, a positive FDA decision could boost this even further. However, generic drugmakers are already challenging the US patents protecting the product in the hope of being able to produce cheaper versions of the drug, potentially influencing its future success.

Source: Datamonitor

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