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Inebilizumab - Horizon Therapeutics plc

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Drug Profile

Inebilizumab - Horizon Therapeutics plc

Alternative Names: 16C4-aFuc; A-fucosylated anti-CD19 antibody; Anti-CD19 MAb-Horizon Therapeutics plc; Inebilizumab-cdon; MEDI 551; MT-0551; UPLIZNA; VIB-0551

Latest Information Update: 22 Nov 2024

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At a glance

  • Originator Duke University
  • Developer Horizon Therapeutics plc; Jiangsu Hansoh Pharmaceutical; MedImmune; Mitsubishi Tanabe Pharma Corporation
  • Class Antineoplastics; Eye disorder therapies; Immunotherapies; Monoclonal antibodies; Skin disorder therapies
  • Mechanism of Action Antibody-dependent cell cytotoxicity; T lymphocyte stimulants
  • Orphan Drug Status

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

    Yes - Neuromyelitis optica; Scleroderma
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Neuromyelitis optica
  • Phase III Immunoglobulin G4-related disease; Myasthenia gravis; Systemic scleroderma
  • No development reported Renal transplant rejection
  • Discontinued B-cell lymphoma; Chronic lymphocytic leukaemia; Diffuse large B cell lymphoma; Follicular lymphoma; Multiple myeloma; Multiple sclerosis

Most Recent Events

  • 14 Nov 2024 Efficacy and adverse event data from the phase III MITIGATE trial in Immunoglobulin G4 related disease released by Amgen
  • 15 Oct 2024 efficacy data from a phase III trial in Myasthenia gravis released by Amgen
  • 19 Sep 2024 Amgen initiates expanded access programme for Immunoglobulin G4 related disease (In children, In adults, In the elderly) (NCT06590051)

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