Evolocumab

Drug Profile

Evolocumab

Alternative Names: AMG-145; Repatha

Latest Information Update: 28 Jul 2017

$50 / €47 *
* $ price applies to USA, Canada and Latin America. € price applies to the rest of the world. Final gross prices may vary according to local VAT.

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

  • 27 Jul 2017 US FDA grants priority review status to sBLA filed for inclusion of cardiovascular outcomes data in the label for evolocumab
  • 05 Jun 2017 Amgen files sBLA for inclusion of cardiovascular outcomes data in the label for evolocumab in USA
  • 05 Jun 2017 Amgen files a variation to the marketing authorisation to the European Medicines Agency for inclusion of cardiovascular outcomes data in the label for evolocumab in European Union
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