FDA rejects Merck’s new cholesterol drug

Source: Healthcare Digital

Date :29/04/2008 01:30:33

An experimental cholesterol drug being developed by Merck & Company has failed to win approval from the Food and Drug Administration, the company said on Monday.

Merck said the agency issued a “not approvable” letter, stating that it needed more information on the drug, Cordaptive. It declined to discuss details and would not comment on whether the agency had asked for further data or new clinical trials.

Disappointment

The drug, also known as MK-0524A, combines an extended-release form of the B vitamin niacin with a chemical to inhibit a niacin side effect called flushing — redness, burning and tingling of the face.

Analysts widely expected the drug to be approved, especially after a committee of European regulators last week recommended it be cleared for sale there.

Deutsche Bank analyst Barbara Ryan called the news a disappointment. "We expected the drug to get approved," she said. "It's not going to have any impact on the earnings outlook for this year, but certainly as we go out in time they could have had an important contribution from the drug."

MK-0524A

Merck said it would meet with the FDA to submit additional information to enable the agency to further evaluate the benefits and risks of the drug, which it has gone back to calling MK-0524A after the F.D.A. rejected Cordaptive as a brand name.

"We firmly believe that MK-0524A provides physicians with an important option to manage their patients' cholesterol," Merck's research chief Peter Kim said in a statement.

Merck disclosed the agency’s action after the close of market trading. Its stock fell five percent, to $39.35 a share, in after-hours trading on Monday.

April 29, 2008