Tredaptive Recommended For EU Approval For The Treatment Of Mixed Dyslipidaemia And Primary Hypercholesterolaemia

Main Category: Cholesterol
Also Included In: Blood / Hematology;  Statins;  Diabetes
Article Date: 28 Apr 2008 - 1:00 PDT

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Merck Sharp & Dohme Limited (MSD) announced that the Committee for Medicinal Products for Human Use (CHMP) has recommended marketing approval for 'Tredaptive'™ (nicotinic acid/laropiprant, MSD) 1000 mg / 20 mg modified-release tablets for the treatment of mixed dyslipidaemia and primary hypercholesterolaemia. 'Tredaptive', the name of 'Cordaptive'™ (ER niacin/laropiprant) in the European Union (EU), combines a modified-release nicotinic acid (niacin) and laropiprant, a novel flushing pathway inhibitor.

The proposed indication for MR nicotinic acid/laropiprant is for the treatment of dyslipidaemia, in particular in patients with combined mixed dyslipidaemia which is characterised by elevated levels of LDL-cholesterol (LDL-C) and triglycerides and low levels of HDL-cholesterol (HDL-C), or primary hypercholesterolaemia (heterozygous familial and non-familial). MR nicotinic acid/laropiprant should be used in combination with a statin when the cholesterol lowering effect of statins is inadequate, or as monotherapy when statins are considered inappropriate or not tolerated. Diet and other non-pharmacological treatments, such as exercise and weight loss, should continue during therapy with MR nicotinic acid/laropiprant.

The CHMP issued a positive opinion following a review of comprehensive data supporting the efficacy, safety and tolerability profile of MR nicotinic acid/laropiprant.

Marketing authorisation from the European Commission is expected by early July and will apply to the 27 countries that are members of the EU, plus Norway and Iceland. The CHMP recommendation applies only to the EU and not to decisions pending with other worldwide regulatory agencies.

About Merck Sharp & Dohme

Merck Sharp & Dohme Limited (MSD) is the UK subsidiary of Merck & Co., Inc., of Whitehouse Station, New Jersey, USA, a leading research-based pharmaceutical company that discovers, develops, manufactures and markets a wide range of innovative pharmaceutical products to improve human health. http://www.msd-uk.co.uk

Forward-Looking Statement

This press release contains "forward-looking statements" about product development, product potential or about financial performance based on current expectations of the management of Merck & Co., Inc. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Merck & Co., Inc. undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.

Merck Sharp & Dohme