Evolocumab - Amgen

Drug Profile

Evolocumab - Amgen

Alternative Names: AMG-145; Repatha

Latest Information Update: 05 Dec 2017

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At a glance

  • Originator Amgen
  • Developer Amgen; Amgen Astellas BioPharma
  • Class Antihyperlipidaemics; Monoclonal antibodies
  • 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 Hypercholesterolaemia; Hyperlipoproteinaemia type IIa

Most Recent Events

  • 01 Dec 2017 The US FDA approves inclusion of cardiovascular outcomes data in the label for evolocumab
  • 15 Nov 2017 Updated efficacy data from the phase III GLAGOV trial in Hypercholesterolaemia presented at the 90th Annual Scientific Sessions of the American Heart Association (AHA-2017)
  • 25 Oct 2017 FDA assigns PDUFA action date of 02 December 2017 for inclusion of cardiovascular outcomes data in the label for evolocumab
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