Zontivity Approved by FDA for Blood Clots

May 9, 2014
Rachel Lutz

Zontivity (vorapaxar) was approved by the US Food and Drug Administration to reduce risk of heart attack, stroke, and cardiovascular (CV) death.

The US Food and Drug Administration (FDA) approved Zontivity (vorapaxar) to reduce the risk of heart attack, stroke, and cardiovascular (CV) death. Another intended use is to restore blood flow to the heart in patients with blockages in leg arteries.

Zontivity is the first in a new class of drugs, protease-activated receptor-1 (PAR-1) antagonists. The drug is designed to decrease the tendency of blood platelets to clump, causing blood clots.

“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,” Ellis Unger, MD, director of the Office of Drug Evaluation I, FDA’s Center for Drug Evaluation and Research, said in a press release.

The trial included more than 25,000 participants and found that Zontivity, when added to other anti-platelet agents such as aspirin and clopidogrel, reduced the rate of heart attack and CV death, and improved blood flow to the heart.

Because Zontivity decreases blood clotting, it increases the risk of bleeding, including life-threatening and fatal bleeding.

The drug is made by Merck Sharp & Dohme Corp., a sector of Merck & Co., Inc.