FDA approves Zontivity tabs

SILVER SPRING, Md. — The Food and Drug Administration on Thursday approved Zontivity (vorapaxar) tablets, an anti-platelet agent that's designed to decrease the tendency of platelets to clump together to form a blood clot. Zontivity is the first in a new class of drugs called a protease-activated receptor-1 (PAR-1) antagonist, the agency said.

“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. In the study that supported the drug’s approval, Zontivity lowered this risk from 9.5% to 7.9% over a 3-year period — about 0.5% per year,” said Ellis Unger, M.D., director of the Office of Drug Evaluation I in the FDA’s Center for Drug Evaluation and Research.

Zontivity, similar to other drugs that inhibit blood clotting, increases the risk of bleeding, which includes life-threatening and fatal bleeding. The drug is not to be used in people who have suffered a stroke, transient ischemic attack or bleeding in the head, as the risk of bleeding in the head is too great.

Zontivity is made by Merck Sharp and Dohme Corp., a subsidiary of Merck of Whitehouse Station, N.J.


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