The FDA has accepted a New Drug Application (NDA) submitted by Merck for the cardiovascular drug vorapaxar.
Vorapaxar is a thrombin receptor antagonist that is being proposed as a secondary prevention of cardiovascular events in patients with a history of heart attack and no history of stroke or transient ischemic attack.
In a presentation at ACC.12, MI patients who received once daily 2.5 mg dose of vorapaxar with aspirin for diagnosed atherosclerosis had an almost 20 percent reduction in cardiovascular events compared with placebo. Overall, cardiovascular death or MI occurred in 7.3 percent in the vorapaxar group vs. 8.2 percent in the placebo group. But there were concerns about rates of bleeding in patients with a previous incidence of stroke.
The NDA has been accepted for standard review, which sets a goal date of within 10 months.