Merck cholesterol drug nets CE Mark, despite FDA rejection
Merck's Tredaptive (nicotinic acid/laropiprant) 1 g/20 mg modified-release tablets, a new lipid-modifying therapy for patients with dyslipidemia and primary hypercholesterolemia, has been approved for marketing in the European Union, Iceland and Norway.
Tredaptive, which is known as Cordaptive in the U.S., combines nicotinic acid (niacin) and laropiprant, a flushing pathway inhibitor. In clinical studies involving more than 4,700 patients, Tredaptive reduced LDL-cholesterol levels, raised HDL-cholesterol levels and decreased triglycerides, the Whitehouse Station, N.J.-based company said.
Merck said that the drug should be used in patients in combination with statins, when the cholesterol lowering effects of statin monotherapy is inadequate. Tredaptive can be used as monotherapy only in patients in whom statins are considered inappropriate or not tolerated.
The FDA rejected the drug for approval in April, stating that more safety and efficacy data were required.
Tredaptive, which is known as Cordaptive in the U.S., combines nicotinic acid (niacin) and laropiprant, a flushing pathway inhibitor. In clinical studies involving more than 4,700 patients, Tredaptive reduced LDL-cholesterol levels, raised HDL-cholesterol levels and decreased triglycerides, the Whitehouse Station, N.J.-based company said.
Merck said that the drug should be used in patients in combination with statins, when the cholesterol lowering effects of statin monotherapy is inadequate. Tredaptive can be used as monotherapy only in patients in whom statins are considered inappropriate or not tolerated.
The FDA rejected the drug for approval in April, stating that more safety and efficacy data were required.