Merck shares fall following FDA rejection of cholesterol drug

WHITEHOUSE STATION, N.J. The Food and Drug Administration yesterday sent a not approvable letter to Merck for its application for the compound MK-0524A, otherwise known as Cordaptive, according to published reports. The drug is a compound of extended-release niacin and laropiprant that can be used alone or with a statin as adjunctive therapy to diet for the treatment of elevated LDL cholesterol, low HDL cholesterol, and elevated triglyceride levels.

In the FDA's letter, the agency rejected the proposed trade name Cordaptive for MK-0524A. The company said at the appropriate time it expects to pursue the alternative trade name Tredaptive for use in the U.S.

Merck’s executive vice president and president, research laboratories Peter Kim said that company, “plans to meet with the FDA and to submit additional information to enable the agency to further evaluate the benefit/risk profile of MK-0524A.”

The agency had accepted Merck’s application for the drug back in late August.

As a result of the “not approvable” letter, stock shares for Merck fell by 5 percent in after-hours trading after closing the day up by 1.8 percent. This is the second time this month that Merck share have fallen over the concerns of a drug. Earlier this month, stocks fell after the American College of Cardiology physicians advised doctors to prescribing the cholesterol drug Vytorin because it was not as effective as other drugs in slowing down atherosclerosis.