FDA advisory panel votes to approve Merck & Co’s vorapaxar

There was a positive outcome for US pharma giant Merck & Co (NYSE: MRK) yesterday, when a US Food and Drug Administration advisory panel voted in favor of approving the firm’s antithrombotic vorapaxar, which will carry the trade name Zontivity if approved.

Members of the Cardiovascular and Renal Drugs Advisory Committee voted 10 to one recommending clearance of vorapaxar, a novel thrombin receptor antagonist, as an adjunctive treatment for reducing atherothrombotic events in patients with a history of myocardial infarction.

Panellists agreed with Merck’s views that the drug should not be used in patients with a history of stroke, since there was an increased risk of bleeding in the brain in this group of patients. "I think this drug addresses a real unmet medical need," said Philip Sager, consulting professor of medicine at Stanford University School of Medicine who chaired the Committee.