Zontivity vorapaxar regulatory update

FDA approved an NDA for Zontivity vorapaxar from Merck to reduce thrombotic cardiovascular events in patients with a history of myocardial infarction (MI) or with peripheral arterial disease (PAD). The label says the drug has been shown to reduce the rate of a combined endpoint of cardiovascular death, MI, stroke and urgent coronary revascularization. The label also includes a black box warning on the risk of bleeding. FDA's Cardiovascular and Renal Drugs Advisory Committee backed approval of the drug in January (see BioCentury, Jan. 20). ...