The company announced Wednesday that the Food and Drug Administration has accepted its cholesterol drug CORDAPTIVE for standard review. That means the decision on whether it'll be approved is due at the end of the second quarter of next year.
CORDAPTIVE is a combination of Merck's extended-release niacin and laropiprant, a novel flushing pathway inhibitor. Niacin is the only medicine that reduces LDL cholesterol -- that's the bad kind -- raises good HDL cholesterol, and reduces the amount of fat in the blood. But it has a side effect called flushing that has kept it from being widely used. No, it doesn't make people have to go to the bathroom; it turns the users beet red and makes them feel unpleasantly hot.
Merck hasn't released the data from the phase 3 trial that supports the application yet; it's scheduled to present the data this weekend at a scientific meeting of the European Society of Cardiology. But insiders have hinted that the drug reduces the bad cholesterol by 21% and does a good job of increasing the good cholesterol.
The drug will compete with Abbott Labs'
Merck asked the FDA to approve CORDAPTIVE for use either by itself or in combination with statins. The combination treatment should help it in the competitive cholesterol market because it won't have to compete against Pfizer's
However, the new drug could take sales away from its two other cholesterol drugs, Zetia and Vytorin, which lower LDL cholesterol levels but do nothing for the good cholesterol. That wouldn't be all that bad, though, because Merck shares the revenue from those two drugs with Schering-Plough
The biggest worry with getting CORDAPTIVE approved is probably not with its effectiveness, but with safety. Not much is known about the long-term effects from use of the flushing inhibitor, and the FDA might require Merck to run a long study to ensure that the drug is safe. If Merck is able to alleviate that worry and get an approval next year, CORDAPTIVE could become Merck's next big blockbuster.