The Food and Drug Administration has rejected one of Merck's new blockbuster drug, a cholesterol-lowering medicine Cordaptive or MK-0524A. The agency sent a Not Approvable action letter for the company's New Drug Application (NDA) for MK-0524A (ER niacin/laropiprant) for the treatment of primary hypercholesterolemia or mixed dyslipidemia.
"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 S. Kim, Ph. D. executive vice president and president, Merck Research Laboratories.
"We firmly believe that MK-0524A provides physicians with an important option to manage their patients' cholesterol. We are encouraged that on April 24, the Committee for Medicinal Products for Human Use (CHMP) recommended marketing approval for MK-0524A in Europe, and we will continue to pursue approval within individual markets in the EU and around the world," added Dr. Kim.
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 United States.
"Merck's broad portfolio of medicines and vaccines, including eight products in launch phase, enables us to weather challenges that come our way," said Richard T. Clark, chairman, president and chief executive officer, Merck. "The company remains confident that we will grow our business this year and achieve the goals outlined in our plan to win."