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FDA Advisors Recommend Approval of Anti-Clot Drug Vorapaxar

Global trial provides supportive data (January 13)

The FDA’s Cardiovascular and Renal Drugs Advisory Committee (CRDAC) has recommended that the agency approve the anticoagulant drug vorapaxar (Zontivity, Merck) as adjunctive therapy in patients with a history of myocardial infarction (MI), based on “robustly positive” study results.

The panel’s opinion was issued 2 days before a scheduled meeting to discuss the drug’s approvability.

Vorapaxar is an orally available, reversible direct antagonist of the protease-activated receptor-1 (PAR-1). This receptor is present on platelets and promotes platelet aggregation when activated by thrombin.

According to the panel, substantial evidence of efficacy was provided by the TRAP 2oP trial, a global, placebo-controlled study involving 26,499 subjects with at least one of three atherosclerotic conditions: prior MI, prior ischemic stroke, or established peripheral arterial disease. The subjects were randomly assigned to receive vorapaxar 2.5 mg once daily or placebo.

In this trial, the primary endpoint of time to cardiovascular (CV) death, MI, stroke, or urgent coronary revascularization was met: 3-year rates of 12.4% for vorapaxar versus 11.2% for placebo (hazard ratio = 0.88; P = 0.001). The key secondary endpoint of time to CV death, MI, or stroke was also met with a nearly identical hazard ratio (P < 0.001).

The FDA is not obligated to follow the advice of its advisory committees, but it usually does so.

Sources: FDA; January 13, 2014; and Reuters; January 13, 2014.

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