FDA likely to approve MSD’s secondary prevention antiplatelet drug

MSD, known as Merck in the US, has received a positive opinion from the FDA’s advisers for vorapaxar, (Zontivity, proposed brand name). The antiplatelet drug has been recommended for approval by the US regulator’s cardiovascular and renal drugs advisory committee, which voted 10-1 in favour.

The anticlotting agent would be the first in a new class of drug, a protease-activated receptor-1 (PAR-1) antagonist. It is designed to reduce atherothrombotic events, “when added to standard 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.

“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.”

Daniel Bloomfield, vice-president, cardiovascular diseases, Merck Research Laboratories.

 

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Related news:

FDA advisory panel votes in favour of approval for Merck’s vorapaxar (Forbes).

Surge in shares of Merck over chances of vorapaxar drug approval (French Tribune).

FDA advisory panel backs Merck’s blood clot-preventing drug (Reuters).

Reference link:

Merck statement on FDA advisory committee for vorapaxar, Merck’s investigational antiplatelet medicine (Merck press release).

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