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
2015-07-21 07:02 ET - News Release
Critical Milestone for Patients With Uncontrolled Cholesterol who Require Additional Intensive LDL-C Reduction
THOUSAND OAKS, Calif., July 21, 2015 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that 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. Repatha is a human monoclonal antibody that inhibits PCSK9, a protein that reduces the liver's ability to remove LDL-C, or "bad" cholesterol, from the blood.1 Elevated LDL-C is an abnormality of cholesterol and/or fats in the blood,2,3 and is recognized as a major risk factor for cardiovascular disease (CVD).4,5
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The EC approved Repatha 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.
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.6 The health care cost of CVD in the European Union (EU) is approximately €106 billion per year.7
"We are proud that our cholesterol-lowering medication, Repatha, is the first PCSK9 inhibitor to be approved by any regulatory agency in the world," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "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."
One high-risk patient group includes those with familial hypercholesterolemia (FH), an inherited condition caused by genetic mutations which lead to high levels of LDL-C at an early age.8 It is estimated that less than one percent of people with FH (heterozygous and homozygous forms) in most countries are diagnosed.9
"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."
Approval from the EC grants a centralized marketing authorization with unified labeling in the 28 countries that are members of the EU. Norway, Iceland and Liechtenstein, as members of the European Economic Area (EEA), will take corresponding decisions on the basis of the decision of the EC.
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.16
The adverse event profile for Repatha was comparable overall to that of the control groups.11-17 The most common adverse reactions that occurred in greater than or equal to 2 percent of the Repatha group, and more frequently than in the control group, were nasopharyngitis, upper respiratory tract infection, back pain, arthralgia, influenza and nausea. Please consult the Summary of Product Characteristics (SmPC) for full safety information.
Repatha is for subcutaneous injection into the abdomen, thigh or upper arm region. Injection sites should be rotated and injections should not be given into areas where the skin is tender, bruised, red or hard. Repatha must not be administered intravenously or intramuscularly. Before starting treatment with Repatha, secondary causes (non-genetic) of excess cholesterol and abnormal fat levels in blood should be excluded. The medicine can only be obtained with a prescription.
The recommended dose for adults with primary disease is either 140 mg every two weeks or 420 mg (the contents of three pre-filled syringes) once a month; both doses are clinically equivalent. For adults or children older than 12 years with homozygous FH, the initial recommended dose is 420 mg once a month. If a response is not achieved after 12 weeks of treatment, the dose can be increased up to 420 mg every two weeks. For more information, see the package leaflet.
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