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Merck moves to suspend worldwide availability of Tredaptive
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Merck announced today that the company plans to suspend the availability of extended-release niacin and laropiprant tablets globally, according to a press release. The drug is currently not approved for use in the United States.
The company’s decision comes in the wake of preliminary data from the HPS2-THRIVE study showing that extended-release niacin and laropiprant (Tredaptive) failed to meet its primary endpoint — reduction of major vascular events. Additionally, researchers found a statistically significant increase in the incidence of some types of nonfatal, serious adverse events in the niacin and laropiprant group vs. a group receiving statin therapy. The decision to withdraw availability is in line with the European Medicine Agency’s Pharmacovigilance Risk Assessment Committee’s recommendation, which was based on the trial’s results, the release stated.
Merck has started informing regulatory agencies of its decision in countries where the drug is currently available. The company is also recommending that physicians stop prescribing extended-release niacin and laropiprant and that treatment plans be reviewed for patients already taking the drug so that changes in therapy can be made in a timely manner. However, Merck is also urging patients not to discontinue therapy without consulting with their health care provider.