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: 08 Aug 2018

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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
  • Phase III Coronary artery disease

Most Recent Events

  • 02 Aug 2018 FDA assigns PDUFA action date of 24/08/2018 for alirocumab for use with apheresis
  • 02 Aug 2018 Regeneron submits an MAA for alirocumab for cardiovascular risk reduction
  • 02 Aug 2018 Regeneron submits sBLAs for alirocumab for cardiovascular risk reduction and Hyperlipidaemia (First-line treatment)
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