Merck & Co. announced that regulators in the EU, Iceland and Norway approved cholesterol drug Tredaptive (nicotinic acid/laropiprant) for the treatment of dyslipidaemia and primary hypercholesterolaemia.
Regulators’ decisions were based in part on results from clinical studies involving more than 4700 patients, which showed that treatment with the drug reduced LDL-cholesterol levels, raised HDL-cholesterol levels and decreased triglycerides.
Merck specified that Tredaptive should be used in combination with statins when statin monotherapy is inadequate, or as a monotherapy for patients in whom statins are considered inappropriate. The FDA rejected the drug in April, and last month Merck indicated that the US regulator requested additional data for the compound from a study scheduled to conclude in 2013.
The drugmaker said that it will try to respond to the agency's request earlier, but does not anticipate doing so before 2010.