'Zontivity' Wins FDA Approval to Reduce Risk of Heart Attacks and Stroke

Merck Sharp & Dohme Corp's 'Zontivity' received a green signal from the U.S. Food and Drug Administration to lower the risk of heart attacks and stroke.

In a latest announcement, the federal regulators announced the approval of a new drug Zontivity, to lower the risk of heart attack, stroke, cardiovascular death and the need for procedures to restore the flow of blood to heart in all those with a previous heart attack or blockage in arteries to the legs.

Approved under the market name Vorapaxar, the pills is an anti-platelet agent that is designed to curb platelets and blood clots.  By eliminating the formation of blood clots the new drug lowers the risk of heart attack and stroke. Zontivity is the first in a novel class of drug called protease-activated receptor-1 (PAR-1) antagonist.

Similar to the other drugs that inhibit clotting, Zontivity is known to elevate the risk of bleeding, which can be life threatening.  One of the most common adverse reaction among those taking Zontivity was bleeding.  Due to this the drug has a boxed warning cautioning the health care professionals about the risk.

The drug should be strictly kept far from those who have stroke, transient ischemic attack or bleeding in head.

"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," said Ellis Unger, M.D., director of the Office of Drug Evaluation I in the FDA's Center for Drug Evaluation and Research.

Those patients given the new drug should be informed that they may bleed and bruise more easily due to the intake of the drug. Any episode of unanticipated, prolonged or excessive bleeding or blood in urine or stool should be brought to the notice of the health care professionals.

The drug will carry a FDA approved patient Medication Guide that carries instructions on use and safety details.

 The safety and effectiveness of the drug was tested in a clinical trial conducted on 25,000 participants. During the test the newly approved tablet Zontivity was added to other anti-platelet agent. They saw the  rate of heart attack, stroke, cardiovascular death and urgent procedures to enhance blood flow to heart was less in those taking Zontivity when compared to those taking a placebo.