The European Medicines Agency (EMA) has recommended that the marketing, supply, and authorisations of three identical niacin/laropiprant products—Tredaptive, Pelzont, and Trevaclyn—for the treatment of adults with dyslipidemia be suspended across the European Union.
In addition, the company that markets the combination, Merck, has begun working with regulatory agencies in all countries where the medicine is currently available to develop communications for healthcare providers and to suspend the availability of the product, with the timing to be based on individual country regulations and processes.
The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) made its decision at its January 7-10, 2013 meeting, where it assessed available data related to safety concerns over the products, which were authorised throughout the EU in 2008. The medicine has been marketed under one of these three trade names by Merck Sharp & Dohme in all EU Member States except Bulgaria, France, and Romania.
The moves are in response to the failure of the HPS-2 THRIVE study to show any clinical benefit of adding extended-release niacin/laropiprant to statin therapy, reported last month. After nearly four years of follow-up, the combination did not significantly reduce the risk of the composite of coronary deaths, nonfatal MI, strokes, or coronary revascularisations compared with statin therapy, but it did significantly increase the risk of nonfatal but serious side effects. Following the announcement, Merck said it no longer planned to take the drug before the US Food and Drug Administration to gain approval.
Merck is recommending that physicians stop prescribing Tredaptive (or identical products) and that they review treatment plans for patients taking it, in a timely manner, to discontinue it and consider other changes in therapy to achieve their dyslipidemia management goals. Patients with questions should speak with their healthcare provider and not discontinue therapy without first speaking with their physician, the company notes.
The PRAC recommendation will be considered by the EMA’s Committee for Medicinal Products for Human Use (CHMP), which is expected to adopt a final scientific opinion on this at its meeting next week, January 14-17, 2013.
- European Medicines Agency. Tredaptive, Pelzont, and Trevaclyn. January 11, 2013. Available here.
- European Medicines Agency. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 January 2013. Available here.
- Merck. Merck provides update on next steps for Tredaptive (extended-release niacin/laropiprant). January 11, 2013. Available here.