Evolocumab: First Global Approval

Drugs
Anthony Markham

Abstract

Evolocumab (Repatha™) is a fully human monoclonal antibody developed by Amgen that has been approved as a treatment for hypercholesterolaemia in the EU, and is awaiting approval in the USA and Japan. It specifically binds proprotein convertase subtilisin/kexin type 9 (PCSK9)-a negative regulator of low-density lipoprotein (LDL)-receptors-thereby improving the ability of the liver to bind LDL-cholesterol (LDL-C), leading to reduced LDL-C blood levels. The drug reduces LDL-C levels in patients with hypercholesterolaemia when used as monotherapy or in conjunction with a statin. This article summarizes the milestones in the development of evolocumab leading to this approval for the treatment of adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia as an adjunct to diet with or without a statin and/or other lipid lowering therapies, and in adults and adolescents aged ≥12 years with homozygous familial hypercholesterolaemia in combination with other lipid lowering therapies.

References

Apr 1, 2014·The New England Journal of Medicine·Dirk J BlomUNKNOWN DESCARTES Investigators
Apr 3, 2014·Journal of the American College of Cardiology·Michael J KorenUNKNOWN MENDEL-2 Investigators

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Citations

Nov 9, 2016·Molecular Therapy. Nucleic Acids·Alastair G KerrRichard Wade-Martins
Jul 18, 2018·Expert Review of Pharmacoeconomics & Outcomes Research·Slobodan M JankovićMarina Kostić
Dec 23, 2017·Frontiers in Pharmacology·Jayne-Louise E PritchardDylan M Glubb
Nov 27, 2019·Clinica Chimica Acta; International Journal of Clinical Chemistry·Hui-Xian YangDuan-Fang Liao

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