US FDA turns down Merck's ER niacin / laropiprant

The US Food and Drug Administration (FDA) has turned down US drug giant Mrck & Co's new drug application for its drug ER niacin / laropiprant (MK-0524A) for the treatment of primary hypercholesterolemia or mixed dyslipidemia.

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.

"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.

Merck today also reaffirmed its 2008 financial guidance as issued last week and reiterated Merck's confidence in meeting its goal of double-digit annual EPS growth through 2010 excluding certain items.

"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."