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Evolocumab - Amgen

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Drug Profile

Evolocumab - Amgen

Alternative Names: AMG-145; Repatha

Latest Information Update: 02 Sep 2025

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At a glance

  • Originator Amgen
  • Developer Amgen; Amgen Astellas BioPharma; University Hospital Inselspital
  • Class Anti-ischaemics; Antihyperlipidaemics; 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
  • Phase III Coronary artery disease; Dyslipidaemias; Hyperlipidaemia

Most Recent Events

  • 25 Aug 2025 US FDA broadens the use of Evolocumab for Hyperlipoproteinaemia type IIa (In adults)
  • 25 Jul 2025 Amgen completes the phase III VESALIUS-CV trial in Coronary disorders in USA, Canada, Netherlands, Hungary, Germany, Spain, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Czech Republic, Denmark, Estonia, Finland, France, Greece, Iceland, Italy, South Korea, Latvia, Lithuania, Mexico, Poland, Portugal, Romania, Russia, Slovakia, Sweden, Taiwan, Ukraine, United Kingdom (SC) (NCT03872401) (CTIS2018-004565-14)
  • 11 Nov 2023 Interim efficacy data from a phase III trial in hypercholesterolaemia presented at the American Heart Association Scientific Sessions 2023 (AHA-2023)

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