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Lecanemab - BioArctic/Eisai

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Drug Profile

Lecanemab - BioArctic/Eisai

Alternative Names: Anti-amyloid beta protofibril antibody - Eisai; BAN-2401; Lecanemab-irmb; LEQEMBI; Leqembi

Latest Information Update: 17 Apr 2025

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At a glance

  • Originator BioArctic Neuroscience
  • Developer BioArctic; Biogen; Eisai Co Ltd
  • Class Antidementias; Monoclonal antibodies; Neuroprotectants
  • Mechanism of Action Amyloid beta-protein inhibitors
  • 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 Alzheimer's disease
  • Preclinical Brain injuries; Down syndrome

Most Recent Events

  • 03 Mar 2025 Therapeutic Goods Administration (TGA) declines the approval of Lecanemab for Alzheimer’s disease (AD)
  • 12 Feb 2025 FDA assigns PDUFA action date of 31/08/2025 for lecanemab in Alzheimer's disease (Early-stage disease) in USA (SC)
  • 31 Jan 2025 Eisai and BioArctic plan to discuss approval decision for lecanemab with CHMP in a meeting in February 2025

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