Belimumab

Drug Profile

Belimumab

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

Latest Information Update: 25 Mar 2017

Price : $50

At a glance

  • Originator Cambridge Antibody Technology; Human Genome Sciences
  • Developer Assistance Publique Hopitaux de Paris; Cancer Trials Australia; GlaxoSmithKline; Hospital for Special Surgery; Human Genome Sciences; North Shore-Long Island Jewish Health System; University of Pennsylvania
  • Class Antirheumatics; Monoclonal antibodies
  • 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.

    No
  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

    No
  • New Molecular Entity Yes

Highest Development Phases

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

Most Recent Events

  • 01 Feb 2017 GlaxoSmithKline completes a phase III trial in Vasculitis in USA, Canada, Mexico, Peru, Australia, United Kingdom, Ireland, Belgium, Czech Republic, Germany, Hungary, Italy, Poland, Romania, Sweden, Spain, Switzerland, Norway and Russia (NCT01663623)
  • 01 Jan 2017 GlaxoSmithKline initiates enrolment in a phase I trial for Systemic lupus erythematosus in China (IV, Infusion) (NCT02880852)
  • 13 Dec 2016 Preregistration for Systemic lupus erythematosus in Japan (SC)
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