Potential 5-year delay for US cholesterol pill

The launch of a Merck & Co cholesterol pill could be delayed by up to five years after US regulators asked for more data. The Food and Drug Administration's call for new clinical trial results means that a possible approval of MK-0524A (ER niacin/ laropiprant) and MK-0524B (ER niacin/laropiprant/simvastatin) for mixed dyslipidemia, will not take place until 2013.

The US drug major met with the agency to discuss the "not approvable" letter it received last month in response to its New Drug Application for MK-0524A (Marketletter May 5). 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 could file a complete response to the FDA action letter would be 2010. In addition, the firm will not seek approval for MK-0524B in the USA until it files its complete response relating to MK-0524A.