FDA Says OK to Zontivity

The U.S. Food and Drug Administration has approved Merck’s Blood Clot Inhibitor, Zontivity (vorapaxar) to reduce the risk of heart attack, stroke, cardiovascular death, and need for procedures to restore the blood flow to the heart in patients with a previous heart attack or blockages in the arteries to the legs.

“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.

The FDA also says that Zontivity must not be used in people who have had a stroke, transient ischemic attack (TIA), or bleeding in the head, because the risk of bleeding in the head/brain is too great.

“There are approximately 7.6 million Americans who have survived a heart attack. Each year, about 190,000 of them have a
recurrent heart attack, so there remains a need for additional treatment options,” said Dr. Daniel Bloomfield, vice president,
Cardiovascular Diseases, Merck Research Laboratories in a press release.

The clinical trial had over 25k participants.

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