FDA reviewers positive for Zontivity (vorapaxar) for reduction of CV events-Merck Inc.

Reviewers for the FDA are giving vorapaxar (Zontivity) from Merck Inc.,, a novel protease-activated receptor 1 (PAR-1) inhibitor that targets thrombin-induced platelet activation, their support. In documents published two days ahead of the Cardiovascular and Renal Drugs Advisory Committee, a committee that will consider data and vote on the drug's immediate future, the FDA review states that vorapaxar should be approved as an "adjunctive therapy in patients with a history of myocardial infarction to reduce the risk of cardiovascular death, myocardial infarction, stroke, and urgent coronary revascularization."

The FDA review is based on an analysis of clinical-trial data by the agency's scientists and statisticians, and their recommendation will be factored into the advisory committee's decision. Although the advisory committee votes on whether or not a drug should be approved, the ultimate decision remains with the FDA. The FDA typically follows the advice of the advisory committee.