Merck is taking steps to withdraw its cholesterol drug Tredaptive from markets worldwide following preliminary data from the HPS2-THRIVE (Heart Protection Study 2-Treatment of HDL to Reduce the Incidence of Vascular Events) study, and in consultation with regulatory authorities. HPS2-THRIVE did not achieve its primary endpoint of reduction of major vascular events, and there was a statistically significant increase in the incidence of some types of non-fatal serious adverse events. Merck has recommended that physicians stop prescribing the drug. Tredaptive was not approved in the U.S.
“Patients currently taking Tredaptive are our priority, and we are committed to continue to work with regulatory agencies around the world to ensure that physicians have appropriate information as we take steps to suspend the availability of Tredaptive,” said Michael Rosenblatt, M.D., chief medical officer, Merck.