Merck Seeking FDA Approval of Vorapaxar

Healthcare company Merck, known as MSD outside the US and Canada, is seeking FDA approval for its anti-thrombotic drug candidate vorapaxar.

It has taken the first step towards this goal, as the New Drug Application (NDA) filed to the organisation for the investigational medicine has been accepted for standard review.

Vorapaxar is thought to have clinical application in preventing secondary cardiovascular events in patients with no history of myocardial infarction (MI), stroke or transient ischemic attack (TIA).

Findings of a placebo-controlled study published in the European Heart Journal by S. Leonardi, et al. (2013) show that the drug helps to reduce risk of heart attack, especially type 1 MI.

With blood clots contributing to the development of a number of potentially life-threatening medical developments, creation of a new anti-thrombotic drug is hugely valuable.

The 1992 Prescription Drug User Fee Act (PDUFA) standards set a ten-month target for the completion of standard review, so Merck will soon discover if its application has been successful.