Merck’s Tredaptive Is Under Review by EU Regulator

The European Medicines Agency is reviewing Merck & Co.’s Tredaptive after a key study showed the cholesterol treatment to be ineffective and potentially harmful.

The Pharmacovigilance Risk Assessment Committee will review the data and make a recommendation to the panel that oversees human medicines, the London-based EMA said today in a statement. The panel will issue an opinion on the drug next month, the agency said.

Tredaptive, also known as Pelzont and Trevaclyn, was approved for sale in Europe in 2008. The therapy, sold in 70 countries but not in the U.S., combines the vitamin niacin and the experimental medicine laropiprant, added to reduce a face-flushing effect of the drug. Tredaptive was designed to raise levels of HDL, or “good” cholesterol. The pill generated less than $20 million in 2012 sales.

In the study of 25,673 patients, Tredaptive failed to cut heart attacks, strokes, the need for artery-clearing procedures or death from cardiovascular disease more than cholesterol-lowering statin drugs. Patients given Tredaptive plus statin drugs alone or with Zocor were more likely to develop serious, though not life-threatening, side effects, the Whitehouse Station, New Jersey-based company said in a statement yesterday.

Merck said it won’t seek U.S. marketing approval. No one should start taking Tredaptive, Merck said, though the company stopped short of telling people not to use it.

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