Amgen’s Repatha approved as cholesterol-lowering medication in Europe

Amgen has announced that its proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor Repatha has been approved as a cholesterol-lowering therapy in Europe.

The drug has been approved for the treatment of patients with uncontrolled cholesterol who require additional intensive low-density lipoprotein cholesterol (LDL-C) reduction.

More than 60 percent of high-risk patients in Europe are still unable to adequately lower their LDL-C levels with statins or other currently approved lipid-lowering agents. This abnormality of cholesterol and/or fats in the blood is recognised as a major risk factor for cardiovascular disease.

Across ten phase III trials, Repatha has demonstrated substantial and consistent reductions in LDL-C levels, with supporting beneficial changes in other lipid parameters, in approximately 6,000 patients with primary hyperlipidaemia and mixed dyslipidaemia.

Dr Sean Harper, executive vice-president of research and development at Amgen, said: "We are proud that our cholesterol-lowering medication, Repatha, is the first PCSK9 inhibitor to be approved by any regulatory agency in the world."

The company is also currently seeking US regulatory approval for the drug.