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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: 30 Aug 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 Autoimmune disorders; 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

  • 26 Aug 2024 Amgen plans a phase II master protocol study for Systemic lupus erythematosus (SC) (NCT06570798)
  • 05 Jun 2024 Amgen announces intention to file for approval for IgG4-related disease in USA
  • 05 Jun 2024 Efficacy and safety data from a phase III trial in Autoimmune disorders released by Amgen

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