First-In-Class Drug Approved to Reduce MI, Stroke Risk

The FDA has approved Zontivity (vorapaxar; Merck) tablets to reduce the risk of heart attack, stroke, cardiovascular death, and need for coronary revascularization in patients with a previous heart attack or blockages in the arteries to the legs (peripheral arterial disease).

Vorapaxar, an antiplatelet, is the first in its class of protease-activated receptor-1 (PAR-1) antagonists. PAR-1 is a receptor activated by thrombin, known to be a potent platelet activator. Vorapaxar inhibits thrombin-induced platelet aggregation by inhibiting PAR-1 receptors on platelets.

RELATED: Vorapaxar NDA under Review for Prevention of Secondary Cardiovascular Events

In a study enrolling over 25,000 patients, Zontivity, in combination with other antiplatelets (eg, aspirin and clopidogrel), reduced the rate of a combined endpoint of heart attack, stroke, cardiovascular death, and urgent procedures to improve coronary revascularization when compared to placebo (event rate 10.1% vs. 11.8% for placebo). For the secondary composite efficacy endpoint of CV death, MI, and stroke alone, Zontivity demonstrated a 20% relative risk reduction in these patients (7.9% vs. 9.5% for placebo).

Zontivity will be available as 2.08mg tablets in 30- and 90-count bottles. It is expected to be launched in the 3rd quarter of 2014.

For more information call (800) 672-6372 or visit Merck.com.