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Evolocumab - Amgen

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Drug Profile

Evolocumab - Amgen

Alternative Names: AMG-145; Repatha

Latest Information Update: 07 Aug 2026

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At a glance

  • Originator Amgen
  • Developer Amgen; Amgen Astellas BioPharma; University Hospital Inselspital
  • Class Anti-ischaemics; Antihyperlipidaemics; Cardiovascular therapies; Monoclonal antibodies; Vascular disorder therapies
  • Mechanism of Action PCSK9 protein inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Hypercholesterolaemia
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Coronary disorders; Hypercholesterolaemia; Hyperlipoproteinaemia type IIa; Myocardial infarction; Stroke
  • Registered Cardiovascular disorders; Dyslipidaemias
  • Phase III Coronary artery disease; Hyperlipidaemia

Most Recent Events

  • 29 Jul 2026 The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopts a positive opinion, recommending approval of Evolocumab (REPATHA®) for adults with established or at high risk for atherosclerotic cardiovascular disease to reduce cardiovascular risk by lowering LDL-C levels, as an adjunct to correction of other risk factors
  • 24 Jul 2026 Amgen completes a phase I pharmacokinetic trial in Healthy volunteers in USA (SC) (NCT07422285)
  • 30 Apr 2026 Update efficacy data from a phase-III VESALIUS-CV trial in Coronary disorders released by Amgen

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