MSD gains European approval for Tredaptive

Merck Sharp & Dohme, the UK subsidiary of US drug major Merck & Co, has received marketing approval in the European Union for Tredaptive (nicotinic acid/ laropiprant) 1g/20mg modified-release tablets, a lipid-modifying therapy to treat dyslipidemia and primary hypercholesterolemia.

The approval of Tredaptive applies to the 27 countries of the EU, as well as Norway and Iceland, for the treatment of dyslipidemia, particularly in patients with combined mixed dyslipidemia or with primary hypercholesterolemia, in combination with statins, when monotherapy of the latter is inadequate. Tredaptive is only indicated for use as monotherapy for patients in whom statins are considered inappropriate or not tolerated.

Tredaptive combines nicotinic acid and laropiprant, a novel flushing pathway inhibitor. In clinical studies involving more than 4,700 patients, the drug reduced low-density lipoprotein cholesterol levels, raised high-density lipoproteion cholesterol and decreased levels of triglycerides.