US rejects Merck cholesterol drug

WASHINGTON (AFP) — The US Food and Drug Administration on Monday said a new cholesterol drug being tested by Merck was not approvable, while the pharmaceutical giant vowed to press ahead with the application.

The drug, known as MK-0524A, was also denied the right to use the trade name "Cordaptive." Merck said it would "pursue the alternative trade name 'Tredaptive'" in the United States.

"We plan to meet with the FDA and to submit additional information to enable the agency to further evaluate the benefit/risk profile of MK-0524A," said Peter Kim, president of Merck Research Laboratories.

"We firmly believe that MK-0524A provides physicians with an important option to manage their patients' cholesterol," he said in a statement.

"We are encouraged that on April 24, the Committee for Medicinal Products for Human Use (CHMP) recommended marketing approval for ...