January 22, 2014 — The U.S. Food and Drug Administration (FDA)’s Cardiovascular and Renal Drugs Advisory Committee recommended approval of vorapaxar, Merck’s investigational antiplatelet medicine for the reduction of atherothrombotic events, when added to standard of care in patients with a history of heart attack and no history of stroke or transient ischemic attack.
The FDA is not bound by the Committee’s guidance, but takes its advice into consideration when reviewing investigational medicines.
Vorapaxar, proposed trade name Zontivity, is a first-in-class protease-activated receptor-1 (PAR-1) antagonist designed to inhibit the formation of blood clots. PAR-1 is receptor activated by thrombin, a potent platelet activator. Vorapaxar inhibits thrombin-induced platelet aggregation by inhibiting PAR-1 receptors on platelets.
Data supporting the filing of this new drug application are from the 26,449 patient TRA 2°P - TIMI 50 trial, a randomized, double-blind, placebo-controlled study of vorapaxar used in addition to standard therapy including other antiplatelet agents. Patients included in the study had a history of myocardial infarction, ischemic stroke or peripheral artery disease and had a median follow-up of 2.5 years.
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