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Sarilumab - Regeneron/Sanofi

Drug Profile

Sarilumab - Regeneron/Sanofi

Alternative Names: Anti-IL 6 receptor antibody; Anti-interleukin 6 receptor antibody; Kevzara; REGN-88; SAR-153191

Latest Information Update: 19 Feb 2024

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At a glance

  • Originator Regeneron Pharmaceuticals; sanofi-aventis
  • Developer Asahi Kasei Pharma Corp; Regeneron Pharmaceuticals; Sanofi
  • Class Anti-inflammatories; Antirheumatics; Antivirals; Monoclonal antibodies
  • Mechanism of Action Interleukin 6 receptor antagonists
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Rheumatoid arthritis
  • Registered Polymyalgia rheumatica
  • Preregistration Juvenile rheumatoid arthritis
  • Discontinued Ankylosing spondylitis; COVID 2019 infections; Giant cell arteritis; Uveitis

Most Recent Events

  • 19 Feb 2024 Sanofi announces intention to submit a regulatory application for Juvenile rheumatoid arthritis (Sanofi pipeline, February 2024)
  • 01 Feb 2024 FDA assigns PDUFA action date of 10/06/2024 for review of sBLA of Sarilumab for Juvenile rheumatoid arthritis
  • 01 Feb 2024 Sanofi plans regulatory submission for approval of Sarilumab for the treatment of children and adolescents with juvenile rheumatoid arthritis in 2027 in EU and ROW
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