As expected, FDA advisors have voiced strong support for the approval of Merck & Co's bloodthinner vorapaxar.
The Agency's Cardiovascular and Renal Drugs Advisory Committee has voted 10-1 that the drug should be allowed onto the US market as an adjunctive treatment for cutting atherothrombotic events in patients with a history of heart attack.
The decision indicates that Merck has been able to show that the benefits of treatment with its drug outweigh any bleeding risks.
The drugmaker was forced to narrow the target patient population for vorapaxar after trials uncovered an excessive bleeding risk in patients who had suffered a stroke, but it seems that the panel is satisfied that it is safe and effective in the remainder of post-heart attack patients.
Vorapaxar, which is likely to be sold under the trade name 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 back in 2009.
Merck said it is pleased with the Committee's decision, which does not necessarily confirm an imminent FDA approval but does make it more likely.
“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,” noted Daniel Bloomfield, vice president, Cardiovascular Diseases, Merck Research Laboratories.
Merck will no doubt be hoping to get a nice slice of the atherothrombotic disease market, the value of which is forecast to hit a whopping $47 billion by 2022, according to a recent report by Decision Resources.