What do you get when you combine a trial design that failed to show improved patient outcomes, two cholesterol-lowering drugs, and an FDA not-approvable letter? A clinical trial destined for cancellation.
ACHIEVE was testing MK-0524A -- formerly called Cordaptive, before the FDA nixed that name. The drug combines Merck's extended-release niacin with laropiprant, a novel flushing pathway inhibitor. The combo drug lowers bad cholesterol and raises good cholesterol without creating the flushed feeling that regular niacin causes in patients.
Like the Enhance trial, which tested its already-approved drug Vytorin, ACHIEVE was measuring the thickness of an artery to show that the drug could decrease the plaque buildup that leads to heart attacks and other ailments. Unfortunately, the patient population used in both the Enhance and ACHIEVE trials -- people with high cholesterol because of an inherited mutation -- are being treated much better today before entering the trial, compared to when a similarly designed trial for Pfizer's
However, Merck and Schering-Plough
Merck hasn't said why the FDA rejected MK-0524A. It's possible that the agency may require all companies to run a study showing that a cholesterol-lowering drug reduces the rate of cardiac events, such as heart attacks and other complications, before it will approve the drug for less needy patients. This seems to be the case for Isis Pharmaceuticals'
Of course, it could be some minor factor keeping Merck from getting the agency's green light for MK-0524A. We just don't know yet.
In any event,competitors with cholesterol-lowering drugs already on the market, like AstraZeneca's