Merck & Co to drop Tredaptive development in USA

US drug giant Merck & Co (NYSE: MRK) said yesterday that, following disappointing clinical trial results with its cholesterol drug Tredaptive (modified-release nicotinic acid/laropiprant), it does not plan to seek regulatory approval of the product in the USA. Merck’s shares fell almost 3% to $42.35 by early afternoon yesterday.

The company announced that the HPS2-THRIVE (Heart Protection Study 2-Treatment of HDL to Reduce the Incidence of Vascular Events) study of Tredaptive did not meet its primary endpoint. MSD (the name used for the company outside North America) and the investigators are informing regulatory agencies of these results. The company is also preparing communications to health care providers in countries where the medicine is currently available, and will continue to work with regulators to provide updated information to health care providers.

HPS2-THRIVE was independently conducted by the Clinical Trial Service Unit at Oxford University, UK, and funded by MSD. The study enrolled 25,673 patients considered to be at high risk for cardiovascular events. Of those enrolled, 14,741 were from Europe (the UK and Scandinavia) and 10,932 were from China. Patients in the study were followed for a median of 3.9 years. HPS2-THRIVE compared modified release nicotinic acid and laropiprant plus statin therapy versus statin therapy. It was not designed to assess directly the separate effects of either modified-release nicotinic acid or laropiprant.