Policy/Biz

FDA Approves Zontivity, Merck Heart Attack Prevention Drug, For High-Risk Patients

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The FDA has approved Zontivity, a stroke and heart attack prevention drug for patients considered "high-risk." Reuters

The Food and Drug Administration has announced its approval for the Merck heart attack and stroke prevention drug, Zontivity, for high-risk patients who have never suffered from a number of prior conditions.

Zontivity (vorapaxar) tablets are the first in a new class of drug known as protease-activated receptor-1 (PAR-1) antagonists. These drugs, designed to reduce platelets’ ability to clump together and form into clots, reduce the user’s overall chance for stroke and heart attack while increasing his or her chance for bleeding. The FDA’s approval comes with a mandate that all Boxed Warnings carry this risk.

In trials, Zontivity was found to reduce death rates from cardiovascular trauma, including peripheral artery disease (PAD), by 17 percent over the three years it was studied. The drug, if used correctly, could offer consumers who have already suffered heart complications a considerable sense of comfort in their later years, Dr. Eugene Braunwald, who supervised the FDA's study of the drug, told Fox Business.

“A new treatment option like Zontivity is an important advance that can help to lower that risk for appropriate patients taking aspirin, clopidogrel, or both,” he said. Some are ineligible, however. These include people who have already suffered a stroke transient ischemic attack (TIA), or bleeding in the head, as the residual risk for major bleeding is too great.

The FDA advises physicians and health care professionals to caution patients about their increased risk for bleeding and bruising, and that they should report to their doctor any excess bleeding or the presence of blood in their stool or urine following taking Zontivity.

Following the 25,000-subject trial, the FDA now recommends Zontivity to any person who is considered “high-risk,” meaning he or she has already sustained a heart attack or other form of blockage to the heart. When combined with other anti-platelet agents, generally aspirin and clopidogrel, in the FDA’s study, reduced the rate of a combined endpoint of heart attack, stroke, cardiovascular death, and urgent procedures to improve blood flow to the heart compared to a placebo.

“In the study that supported the drug’s approval,” said Dr. Ellis Unger, director of the FDA’s Office of Drug Evaluation I, in a news release, “Zontivity lowered this risk from 9.5 percent to 7.9 percent over a 3-year period — about 0.5 percent per year.”

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