Merck Cardiovascular Drug Zontivity Approved By FDA

Last week, the FDA announced that it approved Merck’s platelet receptor antagonist drug, vorapaxar (Zontivity), for use in patients with a history of myochardial infarction (MI) or peripheral arterial disease (PAD) in the US. This comes after January’s FDA Cardiovascular and Renal Drugs Advisory Committee 10-1 vote in favor of approving the drug.

Vorapaxar is used to treat patients with cardiovascular problems and it has been shown to reduce the risk of myocardial infarction, stroke, cardiovascular death, and revascularization procedures. The drug is classified as a protease-activated receptor-1 (PAR-1) antagonist, which stops platelets from sticking together to form blood clots. The drug also presents a problem for some patients, because it is known to increase bleeding, especially in those who have previously had a stroke. The bleeding caused by the drug can be life-threatening and even fatal. The issues with bleeding caused the FDA to mandate that the drug be dispensed with a patient Medication Guide alerting patients to the bleeding risks.

The approval of vorapaxar comes as a surprise to some because the drug went through its fair share of ups and downs throughout the clinical trials process. In fact, just a few years ago, many industry analysts considered the drug to be a lost cause, Forbes says.  In two large clinical trials—one with more than 26,000 patients — researchers found that vorapaxar resulted in a significant increase in bleeding, including intracranial hemorrhage. But Merck continued to develop and test the drug, finding that data from the TRA2P trial showed promise.

Ellis Unger, director of the FDA’s Office of Drug Evaluation I, says, “In patients who have had a heart attack or who have peripheral arterial disease, this drug will lower the risk of heart attack, stroke, and cardiovascular death…  Zontivity lowered this risk from 9.5 percent to 7.9 percent over a 3-year period – about 0.5 percent per year.”