Repatha™ (evolocumab) Now Approved in the EU
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
Critical Milestone for Patients With Uncontrolled Cholesterol who Require Additional Intensive LDL-C Reduction
July 21, 2015
Amgen 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
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.
- Repatha is the first PCSK9 inhibitor to be approved by any regulatory agency in the world.
- 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
- The adverse event profile for Repatha was comparable overall to that of the control groups. 8-14 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.
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Please consult the Summary of Product Characteristics for full safety information.
Repatha™ is not approved in the U.S.
- Amgen Data on File, Investigator Brochure.
- World Health Organization. Quantifying Selected Major Risks to Health. In: The World Health Report 2002 - Reducing Risks, Promoting Healthy Life. Geneva. 2002:49-97.
- Merck Manuals website.http://www.merckmanuals.com/professional/endocrine_and_metabolic_disorders/lipid_disorders/dyslipidemia.html. Accessed July 2015.
- American Heart Association (2014). Why Cholesterol Matters. http://www.heart.org/HEARTORG/Conditions/Cholesterol/WhyCholesterolMatters/Why-Cholesterol-Matters_UCM_001212_Article.jsp. Accessed July 2015.
- World Health Organization. Global Status Report on Noncommunicable Diseases 2014. Geneva, 2014.
- Halcox JP, et al. Low Rates of Both Lipid-Lowering Therapy Use and Achievement of Low-Density Lipoprotein Cholesterol Targets in Individuals at High-Risk for Cardiovascular Disease across Europe. PLoS One. 2015;10(2).
- Leal J, et al. Economic Costs. In: Nichols M, et al. European Cardiovascular Disease Statistics 2012.
- Koren MJ, Lundqvist P, Bolognese M, et al. Anti-PCSK9 monotherapy for hypercholesterolemia: the MENDEL-2 randomized, controlled phase III clinical trial of evolocumab. J Am Coll Cardiol. 2014;63:2531-2540.
- Robinson JG, Nedergaard BS, Rogers WJ, et al. Effect of evolocumab or ezetimibe added to moderate or high-intensity statin therapy on LDL-C lowering in patients with hypercholesterolemia. The LAPLACE-2 randomized clinical trial. JAMA. 2014;311:1870-1882.
- Raal FJ, Stein EA, Dufour R, et al. PCSK9 inhibition with evolocumab (AMG 145) in heterozygous familial hypercholesterolaemia (RUTHERFORD-2): a randomised, double-blind, placebo-controlled trial. Lancet. 2015;385:331-340.
- Stroes E, Colquhoun D, Sullivan D, et al. Anti-PCSK9 antibody effectively lowers cholesterol in patients with statin intolerance: the GAUSS-2 randomized, placebo-controlled phase 3 clinical trial of evolocumab. J Am Coll Cardiol. 2014;63:2541-2548.
- Raal FJ, Honarpour N, Blom DJ, et al. Inhibition of PCSK9 with evolocumab in homozygous familial hypercholesterolaemia (TESLA Part B): a randomised, double-blind, placebo-controlled trial. Lancet. 2015;385:341-50.
- Blom DJ, Hala T, Bolognese M. A 52-week placebo-controlled trial of evolocumab in hyperlipidemia. N Engl J Med. 2014;370:1809-1819.
- Koren MJ, Giugliano RP, Raal FJ, et al. Efficacy and Safety of Longer-Term Administration of Evolocumab (AMG 145) in Patients With Hypercholesterolemia: 52-Week Results from the Open-Label Study of Long-Term Evaluation Against LDL-C (OSLER) Randomized Trial. Circulation. 2014;129:234-243.