FDA clears vorapaxar to reduce MI, stroke risks

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The FDA approved the antiplatelet drug vorapaxar to reduce the risk of an MI, stroke or cardiovascular death in patients with a prior MI or peripheral artery disease.

Vorapaxar (Zontivity, Merck) is a protease-activated receptor-1 antagonist designed to reduce atherothrombotic events in patients with a history of MI. The FDA followed the advice of its Cardiovascular and Renal Drugs Advisory Committee, which voted 10-1 in favor of the drug in January after reviewing results from TRAP2 and TRACER.

TRAP2 enrolled 26,499 patients with either a prior MI, prior ischemic stroke or established peripheral artery disease. TRACER included almost 13,000 patients with acute coronary syndrome without STEMI within 24 hours of presenting at the hospital.

TRACER was terminated early because of major bleeding in the vorapaxar group. In TRAP2, study of patients with a history of stroke was terminated early while the other groups continued. TRAP2 showed vorapaxar reduced the risk of cardiovascular death, MI or stroke compared to placebo but the rate of bleeding was higher in the vorapaxar group.

Vorapaxar is contraindicated in patients who have had a stroke, a transient ischemic attack or bleeding in the head. The approval includes a Boxed Warning on the label describing the drug’s bleeding risk.

Merck is based in Whitehouse Station, N.J.