EMA starts review of Merck & Co's cholesterol drug Tredaptive

The European Medicines Agency said on December 21 that it has started a review of the safety and efficacy of US pharma giant Merck & Co’s (NYSE: MRK) Tredaptive, Pelzont and Trevaclyn, identical medicines containing the active ingredients nicotinic acid and laropiprant that are used to treat adults with dyslipidemia (abnormally high levels of fat in the blood), particularly combined mixed dyslipidemia and primary hypercholesterolemia.

Last week, Merck revealed that it would not file for approval of Tredaptive in the USA, where it has not yet been approved for marketing, following disappointing clinical trial results (The Pharma Letter December 21). The drug is approved in around 770 countries, including Europe, and marketed in about 40, although in the first nine months of 2012 it garnered sales of just $13 million.

The review was triggered because the Agency was informed by the pharmaceutical company Merck, Sharp & Dohme, a European subsidiary of Merck, of the preliminary results of a large, long-term study comparing the clinical effects of adding these medicines to statins (standard medicines used to reduce cholesterol) with statin treatment alone.