Zontivity vorapaxar regulatory update

FDA's Cardiovascular and Renal Drugs Advisory Committee voted 10-1 in favor of approval for Zontivity vorapaxar from Merck to reduce atherothrombotic events in patients with a history of myocardial infarction (MI). The committee did agree with Merck that the label should be restricted to patients with a history of MI and no prior history of stroke or transient ischemic attack. In the Phase III program for vorapaxar, patients with a prior stroke were discontinued from the trial after an interim analysis showed the patients were at increased risk for intracranial hemorrhage and fatal bleeding. ...