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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: 31 Oct 2019

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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 Immunomodulators; 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
  • Registered Atherosclerosis
  • Phase III Coronary artery disease

Most Recent Events

  • 13 Nov 2019 Sanofi intends to submit regulatory applications for Homozygous familial hypercholesterolemia in 2020
  • 11 Jul 2019 The Düsseldorf Regional Court accepts that alirocumab infringes on Amgen’s European patent directed to antibodies targeting proprotein convertase subtilisin/kexin type 9 (PCSK9) in Germany
  • 08 Jul 2019 Linear Clinical Research completes a phase II trial for Hyperlipoproteinaemia type IIa in Australia (ACTRN12617000401358)
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