Merck globally withdraws its cholesterol drug, Tredaptive

Hannah Blake

pharmaphorum

Merck is taking steps to suspend the availability of its cholesterol drug, Tredaptive tablets worldwide, following a recommendation from European regulators. Tredaptive (extended-release niacin / laropiprant) was not approved for use in the United States.

Last month, Merck published negative preliminary data from the HPS2-THRIVE (Heart Protection Study 2-Treatment of HDL to Reduce the Incidence of Vascular Events) clinical study that was evaluating Tredaptive. The trial 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 in the group that received TREDAPTIVE compared to statin therapy.

Based on these trial results, the European Medicine Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) recommended the suspension of the medicine.

“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.”

Michael Rosenblatt, M.D., Chief Medical Officer, Merck.

Merck is recommending that physicians stop prescribing Tredaptive. Merck is also recommending that physicians review treatment plans for patients taking Tredaptive in a timely manner to discontinue Tredaptive and consider other changes in therapy to achieve their dyslipidemia management goals. In the meantime, Merck is encouraging patients with questions to speak with their healthcare provider, and to not discontinue therapy without first speaking with their physician.

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