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EMA starts probe into MSD's Tredaptive

Will investigate cholesterol drug's safety and efficacy after poor phase III results

Merck and Co - US headquartersThe European Medicines Agency (EMA) has started an investigation into the efficacy and safety of Merck Sharp & Dohme's cholesterol-lowering drug Tredaptive in the wake of disappointing phase III trial data.

MSD - known as Merck & Co in the US - said in December that it had decided not to file for approval of Tredaptive (laropiprant and nicotinic acid) with the US FDA on the back of the results of the 25,000-patient HPS-2 THRIVE study, which were revealed last month.

The trial found that Tredaptive was unable to achieve a significant reduction in coronary deaths, nonfatal heart attacks, strokes and revascularisation procedures compared to statin therapy alone. Furthermore, it was also deemed to have increased the risk of "non-fatal serious adverse events".

At the same time Merck said Tredaptive - which is also sold under the Pelzont and Trevaclyn brand names and is available in 70 countries worldwide - should not be prescribed to any new patients, although those already taking it should continue to do so.

Unlike statins, which reduce levels of harmful low-density lipoprotein (LDL) cholesterol, Tredaptive is designed to raise high-density lipoprotein (HDL) cholesterol which is thought to protect against cardiovascular disease. 

In a statement, the EMA said its review would be undertaken by its Pharmacovigilance Risk Assessment Committee (PRAC) and a recommendation would be delivered to the Committee on Medicinal Products for Human Use (CHMP) later this month.

Tredaptive was first approved in Europe in 2008 and is used to treat adults with dyslipidaemia, particularly combined mixed dyslipidaemia and primary hypercholesterolaemia. 

The product was turned down by the US FDA in the same year and sales are thought to have remained modest at around $50m a year. Merck had hoped the HPS-2 THRIVE study would drives growth for the product.

3rd January 2013

From: Sales, Regulatory



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