July 14, 2008
Merck’s Cholesterol Drug Granted European Approval
Merck Sharp & Dohme has announced that Tredaptive 1g/20mg modified-release tablets, a new lipid-modifying therapy for patients with dyslipidemia and primary hypercholesterolemia, has received marketing approval in the EU, Iceland and Norway.
Merck Sharp & Dohme's Tredaptive combines nicotinic acid and laropiprant, a novel flushing pathway inhibitor. In clinical studies involving more than 4,700 patients, Tredaptive reduced LDL-cholesterol (LDL-C, or 'bad' cholesterol) levels, raised HDL-cholesterol (HDL-C, or 'good' cholesterol) levels and decreased triglycerides.
High LDL-C, low HDL-C and elevated triglycerides are risk factors associated with heart attacks and strokes. Tredaptive is approved for the treatment of dyslipidemia, particularly in patients with combined mixed dyslipidemia and in patients with primary hypercholesterolemia.
Stefan Oschmann, president of Merck Sharp & Dohme, Europe, Middle East, Africa and Canada, said: "The approval of Tredaptive in the EU further reinforces our long-standing commitment to the cardiovascular area by bringing novel and innovative therapies to patients."