The European Commission Approves Amgen’s New Cholesterol-Lowering Medication Repatha™ (evolocumab).
The First PCSK9 Inhibitor to Be Approved in the World for Treatment of High Cholesterol.
A Critical Milestone for Patients with Uncontrolled Cholesterol Who Require Additional Intensive LDL-C Reduction.
Amgen (AMGN): The European Commission (EC) has granted marketing authorization for Repatha™ (evolocumab), the first proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor to be approved in the world, for the treatment of patients with uncontrolled cholesterol who require additional intensive low-density lipoprotein cholesterol (LDL-C) reduction.
The EC approved Repatha for the following:
– 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,
– Alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated and
– The treatment of adults and adolescents aged 12 years and over with homozygous familial hypercholesterolemia (HoFH) in combination with other lipid-lowering therapies.
The effect of Repatha on cardiovascular morbidity and mortality has not yet been determined.
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. Among very high-risk patients, the percentage is increased to more than 80 percent. The health care cost of CVD in the European Union (EU) is approximately €106 billion per year.
Familial hypercholesterolemia (FH) is an inherited condition caused by genetic mutations, which lead to high levels of LDL-C at an early age. It is 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.”
Data show 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 hyperlipidemia and mixed dyslipidemia, including more than 4,500 patients with high cholesterol in 10 Phase 3 trials.10 In these studies, Repatha significantly reduced LDL-C by approximately 55 percent to 75 percent compared with placebo,11-14 and by approximately 35 percent to 45 percent compared with ezetimibe.11,12,14 In patients with homozygous FH, Repatha significantly reduced LDL-C by approximately 15 percent to 30 percent compared with placebo.15 Reduction of LDL-C was maintained with long-term treatment.
Repatha™ (evolocumab) is a human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9).1 PCSK9 is a protein that targets LDL receptors for degradation and thereby reduces the liver’s ability to remove LDL-C, or “bad” cholesterol, from the blood.
Repatha, developed by Amgen scientists, is designed to bind to PCSK9 and inhibit PCSK9 from binding to LDL receptors on the liver surface. In the absence of PCSK9, there are more LDL receptors on the surface of the liver to remove LDL-C from the blood.
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Do we need to say this is good news?
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