FDA advisory panel recommends approval of Merck's vorapaxar


WHITEHOUSE STATION, N.J. — Merck on Wednesday commended the U.S. Food and Drug Administration’s Cardiovascular and Renal Drugs Advisory Committee’s recommendation for approval of vorapaxar. Vorapaxar is the company’s investigational antiplatelet medicine for the reduction of atherothrombotic events, when added to standard of care, in patients with a history of heart attack and no history of stroke or transient ischemic attack.

“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,” stated Daniel Bloomfield, VP cardiovascular diseases for Merck Research Laboratories. “The results of today’s Advisory Committee mark an important milestone in our effort to bring vorapaxar to appropriate patients with a history of heart attack. We look forward to working with the FDA as it completes its review.”

The FDA is not bound by the committee’s guidance, but takes its advice into consideration when reviewing investigational medicines, Merck noted. 



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