healthcare giant Merck & Co., Inc. (MRK: Quote) Friday said it is taking steps to suspend its cholesterol drug Tredaptive or nicotinic acid/laropiprant modified-release tablets globally. The drug has failed to show it could reduce heart attacks and strokes and also raised safety concerns. The company noted that it has begun informing regulatory agencies in countries where the medicine is currently available, about its decision.
Tredaptive is a single-pill combination of niacin, a B vitamin organic compound, with a Merck-developed compound called laropiprant. Tredaptive has been approved in about 70 countries, including in Europe, and is sold in about 40 countries. Sales through the first three quarters of 2012 were about $13 million.
Merck, known as MSD outside the U.S., and Canada, noted that the steps are being taken based on current understanding of preliminary data from the Heart Protection Study 2-Treatment of HDL to Reduce the Incidence of Vascular Events or HPS2-Thrive study, and in consultation with regulatory authorities.
Merck’s decision to suspend availability of the medicine follows recommendation of the European Medicine Agency’s Pharmacovigilance Risk Assessment Committee based on the trial’s results.
On December 20, 2012, the world’s second-biggest drugmaker had announced disappointing results from a study of its cholesterol drug Tredaptive and said it is abandoning plans to seek an approval for the drug from the U.S. Food and Drug Administration.
Merck said Tredaptive failed to show it could reduce heart attacks and strokes, compared with statin drugs, as per the large-scale study known as HSP2-Thrive. The drug also raised safety concerns.
Merck in 2007 sought approval for Tredaptive from the FDA, which rejected the drug and asked Merck to furnish results from the HSP2-Thrive study.
The company said it is recommending that physicians stop prescribing Tredaptive and that physicians review treatment plans for patients taking the drug.
Michael Rosenblatt, chief medical officer of the company stated, “Patients currently taking Tredaptive are our priority, and we are committed to continue to work with regulatory agencies around the world to ensure that physicians have appropriate information as we take steps to suspend the availability of Tredaptive.”
Merck closed Thursday’s regular trading at $42.78 on the NYSE. In the pre-market activity, the shares are down 0.65 percent.
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by RTT Staff Writer
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