FDA to Merck: Wait until 2013 for cholesterol drug
Merck makes a play for generic biologics market
During a recent meeting, FDA officials told Merck that more safety and efficacy data would be required for the approval of MK-0524A and suggested the company wait for results of a cardiovascular outcomes study to be completed in January 2013.
“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, said in a statement.
Back in April, the FDA rejected the brand name Cordaptive and issued Merck a not approvable letter regarding the drug.
Merck said it will continue to discuss with the FDA whether data on the drug can be provided earlier to address the agency's issues.
Merck initially hoped MK-0524A would become a major player in the $18 billion market for cholesterol drugs.
MK-0524A was designed to raise HDL, or “good,” cholesterol in patients -- considered a new direction for treatment.