Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the company is taking steps to suspend the availability of TREDAPTIVE ™ (extended-release niacin/laropiprant) tablets worldwide. TREDAPTIVE is not approved for use in the United States.
Merck is taking these steps based on the current understanding of the 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. As previously reported by Merck ( Dec. 20, 2012 news release), 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 in the group that received TREDAPTIVE compared to statin therapy. The decision to suspend availability of the medicine is aligned with the recommendation of the European Medicine Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) based on the trial’s results.
In countries where the medicine is currently available, Merck has begun informing regulatory agencies of the company’s decision. Merck is working with these agencies to develop communications for health care providers and to suspend the availability of TREDAPTIVE, with the timing to be based on individual country regulations and processes.
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 encourages patients with questions to speak with their health care provider, and to not discontinue therapy without first speaking with their physician.“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.