MSD: Tredaptive gets EU approval

Merck, Sharp and Dohme (MSD) has announced that Tredaptive (nicotinic acid/laropiprant) gas received marketing approval in the European Union (EU) as a new lipid-modifying therapy to treat LDL-cholesterol, HDL-cholesterol and triglycerides.

The compound has been approved as a treatment for patients with primary hypercholesterolemia and dyslipidemia, especially in patients with combined mixed dyslipidemia characterised by high levels of LDL-cholesterol and triglycerides and low levels of HDL-cholesterol.

A combination of niacin and laropiprant, the drug is a novel flushing pathway inhibitor that is recommended for use in conjunction with statins when the cholesterol-lowering effects of stain monotherapy is inadequate.

The compound can also be used as a monotherapy in patients for whom statins are not tolerated or are considered inadequate for other reasons.

Stefan Oschmann, president of MSD for Europe, Middle East, Africa and Canada, said: “The approval of Tredaptive in the EU further reinforces our long-standing commitment to the cardiovascular area by bringing novel and innovative therapies to patients.”

He added the compound offers comprehensive management of all three lipid parameters in a number of patients.

In June 2008, MSD said the cardiovascular outcomes study for ER niacin/laropiprant would be completed in 2013.