Sanofi/B-MS File For Clopidogrel Approval

Sanofi and Bristol-Myers Squibb have filed for marketing approval fortheir antithrombotic drug clopidogrel in the USA and Europe. The companies are hoping for approval at the end of 1997 or early in 1998.

At last year's American Heart Association meeting (Marketletter November 18, 1996), Sanofi and B-MS reported the results of the large-scale CAPRIE (clopidogrel versus aspirin in the prevention of recurrent ischemic events) trial, which found that clopidogrel was associated with significantly fewer events than aspirin (although the actual difference was slight), and was also associated with a lower incidence of gastrointestinal and intracranial bleeding.

The two companies will comarket clopidogrel worldwide, and will promote the drug as "the new standard antithrombotic treatment for the prevention of life-threatening cardiovascular events." Whether the companies achieve this goal will depend on the pricing of clopidogrel, and whether they can convince doctors that the increased cost is worth the marginal increase in efficacy.