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Regulators recommend approval of new Merck clot-reducing drug

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A Food and Drug Administration advisory committee has recommended approval of Merck and Co. drug vorapaxar, a medicine designed to reduce blood clotting for certain patients who have suffered a heart attack.

The FDA is not bound by advisory committee recommendations — in this case the Cardiovascular and Renal Drugs Advisory Committee — but factors them into decisions.

Used in combination with standard treatment, vorapaxar is aimed at patients with a history of a heart attack and no history of stroke. The antiplatelet medicine reduces blood clots by preventing small blood cells from sticking together.

Daniel Bloomfield, vice president of cardiovascular diseases at Merck Research Laboratories, said additional treatments options for heart attack survivors are necessary to prevent second events. Bloomfield noted that of 7.6 million Americans who survive heart attacks annually, about 190,000 of them experience a recurrent attack.

"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," Bloomfield said in a statement. "We look forward to working with the FDA as it completes its review."

Vorapaxar's proposed trade name is Zontivity.


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