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MSD still confidence in MK-0524A potential

23rd June 2008

Merck, Sharp and Dohme (MSD) has said it still has confidence in the potential of MK-0524A (ER niacin/laropiprant).

The company made this statement following a meeting with regulators regarding the regulatory status of the compound and that of MK-0524B (ER niacin/laropiprant/simvastatin).

At that meeting, the company discussed the non-approval letter received from the US Food and Drug Administration (FDA) in April, where the regulator said additional safety and efficacy data were required and suggested MSD wait for the results of the HPS2-Trhive study.

This cardiovascular outcomes study is expected to be completed in January 2013.

MSD said it would continue to meet with the FDA to discuss whether data could be provided before this time to address the issued raised, adding it would not compete a response to the action letter until 2010 at the earliest.

Peter S Kim, executive vice-president of the company and president of Merck Research Laboratories, said: “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.”

In December 2006, MSD said it would make three regulatory filings in 2007, which were MK-0524A, insomnia drug Gaboxadol and HIV integrase inhibitor MK-0518.

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