Merck (MRK) Updates Regulatory Status on MK-0524A and MK-0524B
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Merck & Co., Inc. (NYSE: MRK) today provided an update on the regulatory status in the United States of its investigational medicines MK-0524A and MK-0524B for the treatment of primary hypercholesterolemia or mixed dyslipidemia.
Merck met with the U.S. FDA to discuss the Not Approvable action letter it received on April 28 in response to its New Drug Applicationfor 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 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.
Merck & Co., Inc. provides various products for human and animal health in the United States and internationally.
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