Evolocumab

Drug Profile

Evolocumab

Alternative Names: AMG-145; Repatha

Latest Information Update: 21 Dec 2016

Price : $50

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
  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Hypercholesterolaemia; Hyperlipoproteinaemia type IIa

Most Recent Events

  • 16 Dec 2016 Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommends approval of 420mg evolocumab in European Union, Norway, Iceland and Liechtenstein
  • 15 Nov 2016 Efficacy, pharmacodynamics and adverse events data from the phase III GLAGOV trial in Hypercholesterolaemia presented at the American Heart Association-2016 (AHA-2016)
  • 01 Nov 2016 Amgen completes the FOURIER phase III trial for Hypercholesterolaemia in the US, Europe and several other countries worldwide (SC, Combination therapy) (NCT01764633)
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