Amgen Inc. has announced the European Commission’s marketing authorization for Repatha (evolocumab) for treating patients with uncontrolled cholesterol, requiring additional low-density lipoprotein cholesterol (LDL-C). Evolocumab now becomes the first proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor to be approved anywhere.
The approval gives Amgen’s much anticipated treatment a lead start over Praluent, a competing PCSK9 drug developed by Regeneron Pharmaceuticals Inc and Sanofi SA.
Repatha was approved by the EC for:
The treatment of adults with primary hypercholesterolemia (heterozygous familial and non-familial [HeFH]) or mixed dyslipidemia, as an adjunct to diet
in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin, or
alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated
The treatment of adults and adolescents aged 12 years and over with homozygous familial hypercholesterolemia (HoFH) in combination with other lipid-lowering therapies
Sean E. Harper, M.D., executive vice president of Research and Development at Amgen, said in a statement:
“We are proud that our cholesterol-lowering medication, Repatha, is the first PCSK9 inhibitor to be approved by any regulatory agency in the world. High LDL cholesterol is a major global health burden and many patients are unable to appropriately control their LDL cholesterol with the maximum tolerated dose of a statin, or are unable to take statins due to intolerance or contraindications. We are excited to make this new cholesterol-lowering medication available for patients in Europe.”
Over 60 percent of high-risk patients in Europe are still unable to sufficienty lower their LDL-C levels with statins or other currently approved lipid-lowering agents. And among very high-risk patients, the percentage is increased to more than 80 percent.
The health care cost of cardiovascular disease (CVD) in the European Union is approximately €106 billion per year.
One high-risk patient group consists of those with familial hypercholesterolemia (FH), an inherited condition caused by genetic mutations which lead to high levels of LDL-C at an early age. It has been estimated that less than one percent of people with FH (heterozygous and homozygous forms) in most countries are diagnosed.
“Many patients who are taking cholesterol-lowering therapies, including those with familial hypercholesterolemia, still struggle to control their LDL cholesterol levels,” said John J.P. Kastelein, professor of medicine and chairman of the Department of Vascular Medicine at the Academic Medical Center (AMC) of the University of Amsterdam. “As the first in a new class of drugs in the European Union, evolocumab will offer physicians an important and innovative treatment option for patients with uncontrolled cholesterol who require additional LDL cholesterol reduction.”
Repatha, a human monoclonal antibody, inhibits PCSK9, a protein which lowers the liver’s ability to remove LDL-C, or “bad” cholesterol, from the blood. Elevated LDL-C is an abnormality of cholesterol and/or fats in the blood and is recognized as a major risk factor for CVD.