Sanofi/B-MS' Clopidogrel Backed By US Panel

A US Food and Drug Administration advisory panel has recommended by avote of 10 to one that Sanofi and Bristol-Myers Squibb's new antithrombotic drug Plavix (clopidogrel bisulfate) should be approved for marketing in the USA.

The decision was based on the results of the 19,185-patient CAPRIE (Clopidogrel vs Aspirin in Patients at Risk of Ischemic Events) study, reported at last year's American Heart Association meeting (Marketletter November 18, 1996). This study showed that patients with atherothrombotic disease (including those with peripheral artery disease, stroke and myocardial infarction) who were treated with clopidogrel had a relative risk reduction of 8.7% over aspirin.

Broad Label Should Be Granted However, within the subgroups the relative risk reduction was 7.8% for stroke and 23.8% for PAD, but a risk increase of 3.7% was seen within the MI group. Prior to the advisory committee meeting, there had been speculation that the wide variation in outcomes for the three atherothrombosis subgroups might lead to a restriction in the labeling to just two of the three subgroups. This was not the case, and the panel supported the companies' view that a broad label for the product in all three subgroups should be considered, as the trial was neither designed nor statistically powered to be analyzed by subgroup.