Merck halts U.S. regulatory plans for CV drug Tredaptive

Merck & Co. Inc. (NYSE:MRK) said it does not plan to seek U.S. regulatory approval for Tredaptive and recommended that providers in countries where the cardiovascular drug is approved not start new patients on the drug. The pharma made the decision after data from the investigator-led Phase III HPS2-THRIVE trial showed that Tredaptive plus statin therapy missed the primary endpoint of reducing the composite of coronary death, non-fatal MI, stroke or revascularization vs. statin therapy alone. The trial was evaluating whether raised HDL levels due to Tredaptive would reduce the incidence of vascular events. Merck said Tredaptive plus statin therapy also significantly increased the incidence of types of non-fatal serious adverse events vs. statin therapy alone, but did not disclose details. Detailed data are expected in 1Q13. The trial, which enrolled 25,673 patients at high risk for cardiovascular events, was conducted by researchers at Oxford University and funded by Merck. ...