EU Approves Merck’s Cholesterol Drug
Tredaptive, Merck’s new combination niacin drug that was the subject of an FDA not-approvable letter in April, has been approved in the EU, Norway and Iceland for the treatment of high cholesterol.
The drug is a combination of extended-release niacin and anti-flushing agent laropiprant. The EU approval recommends the product be used with a statin or as a monotherapy when the use of a statin is considered inappropriate, Merck said.
Last month, Merck met with the FDA to discuss its NDA for the product. After the meeting, the company said the FDA wants additional efficacy and safety data and suggested that Merck wait until the results of the drug’s 20,000-patient cardiovascular outcomes study, HPS2-THRIVE, are available.
The study has enrolled 12,000 patients and is expected to be completed in 2013, Merck said. The company has suggested that the earliest it could submit a complete response to the FDA not-approvable letter was 2010.