Alirocumab - Regeneron/Sanofi

Drug Profile

Alirocumab - Regeneron/Sanofi

Alternative Names: ALI; Anti-PCSK9 monoclonal antibody; Anti-proprotein convertase subtilisin kexin type 9 monoclonal antibody; Praluent; REGN-727; SAR-236553

Latest Information Update: 13 Oct 2017

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At a glance

  • Originator Regeneron Pharmaceuticals; sanofi-aventis
  • Developer Regeneron Pharmaceuticals; Sanofi; University Hospital Inselspital
  • 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 - Hyperlipoproteinaemia type IIa
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Hypercholesterolaemia; Hyperlipoproteinaemia type IIa
  • Phase III Coronary artery disease

Most Recent Events

  • 05 Oct 2017 The US Court of Appeals for the Federal Circuit vacates the permanent injunction in a patent case against Amgen regarding alirocumab
  • 26 Aug 2017 Interim adverse events data from a phase III ODYSSEY APPRISE trial in Hypercholesterolaemia presented at the Annual Congress of the European Society of Cardiology (ESC-2017)
  • 10 Aug 2017 Sanofi in collaboration with Regeneron Pharmaceuticals completed enrolment in the phase III ODYSSEY APPRISE trial for Hypercholesterolemia in Austria, Belgium, Czech, Finland, France, Germany, Greece, Hungary, Poland, Romania, Slovakia, Slovenia, Spain, Canada, Denmark and Switzerland, before August 2017 (NCT02476006)
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