This is big setback for the drugmaker, although not unexpected. You may recall, the FDA issued a non-approval lettertwo months ago for Cordaptive, which Merck hoped would revive its cholesterol franchise, now that Zocor is beset by generic rivals and Vytorin is under siege due to the controversial Enhance study.
Now, after meeting with the FDA, Merck is saying the agency suggests the drugmaker wait for the results of a cardiovascular outcomes study called THRIVE (Treatment of HDL to Reduce the Incidence of Vascular Events), which is expected to be completed in January 2013. One Wall Street analyst forecast this development last month (read here). The pill, by the way, contains an extended-release form of niacin, which is a vitamin, and a chemical called laropiprant to stop flushing, a common reaction to niacin.
In a statement, the drugmaker says it will continue to discuss with the FDA whether data on the drug, known as MK-0524A, in hopes of addressing the agency's issues earlier than that far-off date. But even then, the earliest Merck would file a complete response to the agency would be 2010.
"We are disappointed, but continue to have confidence in the potential of MK-0524A to provide physicians with an important option to manage their patients' cholesterol," Peter Kim, president of Merck Research Laboratories, says in the statement. Merck's loss is Abbott's gain - Abbott sells the Simcor cholesterol pill that was approved a few months ago.