Merck’s Vorapaxar Receives Backing from FDA Advisors

Advisors for the US regulatory body, the FDA, have given strong support for the approval of Merck & Co’s bloodthinner drug, vorapaxar.

The US regulatory agency’s Cardiovascular and Renal Drugs Advisory Committee yesterday voted 10-1 in favour of vorapaxar being allowed onto the US market as an adjunctive treatment for cutting atherothrombotic events in patients who have a history of heart attacks.

Merck was forced to reduce the target patient population for vorapaxar after clinical trials revealed an excessive bleeding risk in patients who had suffered a stroke.  The decision suggests that Merck have been able to show that the benefits of vorapaxar outweigh any risks of bleeding.

Vorapaxar, which will probably be sold as Zontivity, is a first-in-class protease-activated receptor-1 (PAR-1) antagonist designed to inhibit the formation of blood clots which the firm acquired through its purchase of Schering-Plough in 2009.

Merck noted that they were happy with the decision, which does not confirm imminent regulatory approval from the FDA, but does make it more likely.

Daniel Bloomfield, vice president, Cardiovascular Diseases, Merck Research Laboratories, commented that “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.”

Merck have suggested that Vorapaxar’s label urges care when prescribing for patients who weigh less than 60 kilograms (132 lbs) since the risk of bleeding in these patients appears to be higher.

The Committee could not reach an agreement on how lower-weight patients should be treated with the drug.  Representatives from the FDA have confirmed that they will continue to discuss the matter before making their final ruling.


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