Merck & Co's NDA for vorapaxar accepted for standard review by US FDA

US pharma giant Merck & Co (NYSE: MRK) has said the New Drug Application (NDA) for its once-troubled investigational anti-thrombotic medicine, vorapaxar, has been accepted for standard review by the US Food and Drug Administration.

Merck is seeking FDA approval of vorapaxar for the secondary prevention of cardiovascular events in patients with a history of heart attack and no history of stroke or transient ischemic attack (TIA).

In 2012 Merck presented mixed results from a study of the drug ( The Pharma Letter March 26 2012). In the study, the addition of vorapaxar to standard of care (eg, aspirin or thienopyridine or both) resulted in a significantly greater reduction in the risk of the composite of cardiovascular death, heart attack, stroke or urgent coronary revascularization. However, treatment with vorapaxar also led to worrying adverse effects of moderate or severe bleeding, as well as an excess of intracranial hemorrhage, in all treated patients, raising concerns about the drug’s safety.