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Merck & Co., Inc. today provided an update on the regulatory status in the United States of its investigational medicines MK-0524A (ER niacin/laropiprant) and MK-0524B (ER niacin/laropiprant/simvastatin) for the treatment of primary hypercholesterolemia or mixed dyslipidemia
WHITEHOUSE STATION, NJ, USA | June 20, 2008 | Merck & Co., Inc. today provided an update on the regulatory status in the United States of its investigational medicines MK-0524A (ER niacin/laropiprant) and MK-0524B (ER niacin/laropiprant/simvastatin) for the treatment of primary hypercholesterolemia or mixed dyslipidemia.
Merck recently met with the U.S. Food and Drug Administration (FDA) to discuss the Not Approvable action letter it received on April 28 in response to its New Drug Application (NDA) for MK-0524A. At the meeting, the FDA stated that additional efficacy and safety data were required and suggested that the Company wait for the results of the HPS2-THRIVE (Treatment of HDL to Reduce the Incidence of Vascular Events) cardiovascular outcomes study, which is expected to be completed in January 2013.
The Company said it will continue to discuss with the FDA whether data can be provided prior to the completion of the HPS2-THRIVE study that would address the issues raised by the agency and allow for an earlier filing. In that event, the earliest Merck would file a complete response to the FDA action letter would be 2010. In addition, Merck will not seek approval for MK-0524B in the United States until it files its complete response relating to MK-0524A.
"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," said Peter S. Kim, Ph.D., executive vice president and president, Merck Research Laboratories.
The clinical development program for MK-0524A continues, including the 20,000-patient HPS2-THRIVE study. That study has already enrolled 12,000 patients. It is being conducted by Oxford University and is funded through a grant from Merck.
In other countries around the world, Merck continues to pursue regulatory approvals for MK-0524A and MK-0524B.
Merck also reiterated its confidence in meeting the Company's goal of double-digit compound annual EPS growth from 2005 through 2010 excluding certain items.
About Merck
Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck currently discovers, develops, manufactures and markets vaccines and medicines to address unmet medical needs. The Company devotes extensive efforts to increase access to medicines through far-reaching programs that not only donate Merck medicines but help deliver them to the people who need them. Merck also publishes unbiased health information as a not-for-profit service. For more information, visit www.merck.com.
SOURCE: Merck & Co. |
