FDA Advisory Committee Recommends Approval of Anti-Thrombotic Drug

An FDA advisory committee on Wednesday voted 10-1 in favor of approving vorapaxar to reduce atherothrombotic events in patients who have had myocardial infarction but no history of stroke or transient ischemic attack. The drug, marketed by Merck, is taken orally at a 2.5 mg dose once daily.

The recommendation was based on a phase 3, randomized, double-blind, placebo-controlled trial that included 26,449 patients with evidence of or a history with atherosclerosis. Patients were randomly assigned in a 1:1 ratio to receive 2.5 mg of vorapaxar or placebo once daily in addition to the standard of care, including aspirin and/or thienopyridine.

Patients in the vorapaxar group had a 12% reduction in cardiovascular death, myocardial infarction, stroke, or urgent coronary revascularization compared with the placebo group (hazard ratio [HR], 0.88; 95% confidence interval [CI], 0.82-0.95; P=.001). Vorapaxar also reduced the secondary end point of cardiovascular death, myocardial infarction, or death by 13% (HR, 0.87; 95% CI, 0.80-0.94; P<.001).

Vorapaxar is contraindicated in patients with a history of stroke, transient ischemic attack, intracranial hemorrhage, or active pathological bleeding.

In a news release, Merck noted that 7.6 million people in the United States have survived a heart attack and that there are approximately 190,000 recurrent heart attacks each year.

Click here for the FDA advisory committee documents.

-Tim Casey