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Belimumab - AstraZeneca/GSK

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Drug Profile

Belimumab - AstraZeneca/GSK

Alternative Names: Anti-BLyS monoclonal antibody; Benlysta; BmAb; GSK1550188; HGS-1006; LSB; LymphoStat-B; monoclonal anti-BLyS

Latest Information Update: 30 Aug 2024

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At a glance

  • Originator Cambridge Antibody Technology; Human Genome Sciences
  • Developer Assistance Publique Hopitaux de Paris; Cancer Trials Australia; GlaxoSmithKline; GSK; Hospital for Special Surgery; Human Genome Sciences; National Institute of Allergy and Infectious Diseases; North Shore-Long Island Jewish Health System; University of Pennsylvania; University of Wisconsin-Madison; Washington University School of Medicine
  • Class Anti-inflammatories; Antineoplastics; Antirheumatics; Immunotherapies; Monoclonal antibodies; Skin disorder therapies; Urologics
  • Mechanism of Action B cell activating factor inhibitors
  • Orphan Drug Status

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

    Yes - Systemic lupus erythematosus
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Lupus nephritis; Systemic lupus erythematosus
  • Phase III Anti-neutrophil cytoplasmic antibody-associated vasculitis; Interstitial lung diseases
  • Phase II/III Myositis; Systemic scleroderma
  • Phase II Membranous glomerulonephritis; Multiple sclerosis; Myasthenia gravis; Renal transplant rejection
  • No development reported Graft-versus-host disease; Waldenstrom's macroglobulinaemia
  • Discontinued Rheumatoid arthritis; Sjogren's syndrome

Most Recent Events

  • 26 Aug 2024 Phase-III clinical trials in Interstitial lung diseases (Treatment-experienced) in Japan (SC) (NCT06572384) (EudraCT2024-513018-36)
  • 04 Dec 2023 700361548: Updated KDM, added devlines and HE.
  • 13 Sep 2023 Phase-II/III clinical trials in Systemic scleroderma in Denmark, United Kingdom, Spain, Mexico, South Korea, Japan, Italy, Israel, Greece, Germany, France, Finland, China, Canada, Brazil, Belgium, Australia, Argentina, USA (SC) (NCT05878717)

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