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FDA Advisory Panel Votes in Favor of Approval for Vorapaxar — Physician’s First Watch

Medical News |
January 21, 2014

FDA Advisory Panel Votes in Favor of Approval for Vorapaxar

By Larry Husten

An FDA advisory panel voted 10-1 last week to approve vorapaxar, a novel thrombin receptor antagonist, as adjunctive therapy for reducing atherothrombotic events in patients after myocardial infarction.

The panel reportedly wrestled with questions raised by the drug's troubled history, in which one large trial, TRACER, was stopped early due to high rates of serious bleeding and another trial, TRA 2P-TIMI 50, was redesigned midstream. But ultimately, the panel believed that TRA 2P-TIMI 50 had shown that vorapaxar was effective post-MI when patients with a history of stroke were excluded.

Asked to comment, Harlan Krumholz, a cardiologist with NEJM Journal Watch, wrote: "It is hard to be enthusiastic about this drug, given its track record in the two pivotal trials. One was stopped early because of safety concerns about bleeding (and without a benefit), and the other one caused almost as many major bleeding events as it saved cardiovascular events. And in both trials the rate of intracranial hemorrhage increased markedly."

Adapted from CardioExchange.

Reader Comments (1)

Jose Angel Hernandez Physician, Rheumatology, Hospital Insular

Hard to understand that treatment is adopted with these risks and little benefit

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