Anti-Clotting drug Zontivity Approved by FDA for Heart Attacks
The U.S. FDA has approved Merck anti-clotting drug Zontivity (vorapaxar) for high-risk group of heart patients. The drug has been recommended for reducing cardiovascular ailment related deaths and stroke.
The drug will be sold under brand name Zontivity in the United States. In January, the FDA panel had voted 10-1 in favor of the drug approval for heart attacks and stroke patients. The delay is approval was due to further checks by FDA team regarding the reports of fatal bleeding among some patients.
Zontivity is among the new class for drugs termed as protease-activated receptor-1 (PAR-1) antagonist. Vorapaxar has been found successful in reducing the tendency of platelets to form blood clots. The anti-platelet agent comes with higher risk of bleeding and doctors should inform patients regarding the risks before starting the treatment, said FDA.
Ellis Unger, M.D., director of the Office of Drug Evaluation I in the FDA’s Center for Drug Evaluation and Research, 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 percent to 7.9 percent over a 3-year period – about 0.5 percent per year.”
Zontivity has not been recommended for patients who have suffered transient ischemic attack (TIA), bleeding in the head or stroke.
Zontivity has proved successful in a clinical trial involving 25,000 patients. The drug reduced the rate of combined endpoint of heart attack and stroke. The standard therapy for reducing risk of second heart attack is aspirin and clot preventer Plavix.
The drug comes with a warning for patients suffering from excessive bleeding. Patients should report long term bleeding, tendency to bleed or bruise easily, blood in urine to their medical expert.
As per Merck, Zontivity reduces the chances of second heart attack. The drug will be manufactured by Merck Sharp & Dohme Corp. Each year, nearly 190,000 patients suffer from second heart attack.
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