FDA Approves Merck & Co.’s Anti-Platelet Agent Zontivity
Merck & Co. has received FDA approval for Zontivity (vorapaxar) tablets to reduce the risk of heart attack, stroke, cardiovascular death, and need for procedures to restore the blood flow to the heart in patients with a previous heart attack or blockages in the arteries to the legs.
Merck has two other drug candidates under FDA review: MK-3475, an investigational anti-PD-1 antibody for treating advanced melanoma, and suvorexant, an investigational orexin inhibitor for the treatment of insomnia. Vaniprevir, an investigational, novel protease inhibitor for the treatment of hepatitis C, is under review in Japan. And V503, an investigational 9-valent HPV vaccine, is under FDA review.
FDA accepted for review the biologics license application (BLA) for MK-3475 earlier this month. FDA granted priority review designation with a PDUFA date of October 28, 2014, and the MK-3475 BLA will be reviewed under FDA's Accelerated Approval program. FDA previously granted MK-3475 Breakthrough Therapy designation for advanced melanoma. If approved by FDA, MK-3475 has the potential to be the first anti-PD-1 antibody in a new class of immune checkpoint modulators. Merck also announced it plans to file a marketing authorization application for MK-3475 in Europe for advanced melanoma by the end of 2014.
FDA accepted a new drug application (NDA) for suvorexant in October 2012 and accepted the resubmission of the NDA in April 2014.
FDA accepted a BLA for V503 in February 2014.