The FDA today approved vorapaxar (Zontivity),\u00a0Merck’s\u00a0once-troubled platelet receptor antagonist, to reduce the risk of myocardial infarction (MI), stroke, cardiovascular death, and revascularization procedures. The drug is approved for use in people with a history of MI or peripheral arterial disease. The approval represents an amazing turnaround for a drug that has experienced nearly as many ups and downs as an amusement park roller coaster.<\/p>\n
Vorapaxar is the first in a new drug class known as protease-activated receptor-1 (PAR-1) antagonists. By preventing the ability of platelets to stick together and form blood clots, the drug can help prevent MI and stroke. But it also increases the risk of bleeding, including life-threatening and fatal bleeding. Because the risk of serious intracranial bleeding is especially high in people who have had a stroke, a transient ischemic attack, or bleeding in the head, use of the drug is contraindicated in these groups. The drug’s label includes a boxed warning about the risk of bleeding. The FDA said the drug\u00a0will be dispensed with a patient Medication Guide.<\/p>\n
Vorapaxar appeared to be all but dead a few years ago after unacceptably high serious bleeding rates were found in\u00a0two large clinical trials<\/a>. But hopes for the drug resurfaced with a new analysis of\u00a0one of those tr<\/a>ials, the TRA2P trial<\/a>.\u00a0In a statement to the press,\u00a0Ellis Unger, director of the FDA’s Office of Drug Evaluation I, said that the trial showed that “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\u2026 \u00a0Zontivity lowered this risk from 9.5 percent to 7.9 percent over a 3-year period \u2013 about 0.5 percent per year.”<\/p>\n