FDA Approves PAR-1 Antagonist Vorapaxar (Zontivity) to Reduce MI, Stroke Risk

Shelley Wood

Disclosures

May 08, 2014

ST PAUL, MN — The US Food and Drug Administration has approved vorapaxar (Zontivity, Merck Sharpe & Dohme), a novel protease-activated receptor 1 (PAR-1) inhibitor, to reduce the risk of MI, stroke, cardiovascular death, and need for revascularization procedures in patients with a previous MI or peripheral artery disease[1].

This is a first-in-class approval for this antiplatelet medication.

The approval comes after a January meeting of the Cardiovascular and Renal Drugs Advisory Committee voted 10 to 1 in favor of approving vorapaxar in this setting. The drug will be packaged with a boxed warning alerting physicians to the risk of bleeding and is contraindicated in people who have had a stroke, transient ischemic attack (TIA), or intracranial hemorrhage because of the increased bleeding risk.

The basis for approval is from the TRA 2°P TIMI-50 clinical trial. Reported by heartwire when it was presented in 2012 at the American College of Cardiology Scientific Sessions , the 26 499-patient study showed that time to cardiovascular death, MI, stroke, or urgent coronary revascularization was reduced by 13% in patients taking 2.5 mg of vorapaxar. When coronary revascularization was excluded, the secondary end point of cardiovascular death, MI, or stroke was also significantly reduced.

On the downside, moderate or severe bleeding occurred in 4.2% of patients treated with vorapaxar compared with 2.5% in the placebo-treated patients, a statistically significant 66% increase.

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