Ofatumumab - Genmab/GlaxoSmithKline/Novartis

Drug Profile

Ofatumumab - Genmab/GlaxoSmithKline/Novartis

Alternative Names: Anti-CD20 monoclonal antibody - Novartis; Arzerra; GSK-1841157; HuMax CD20; OMB-157

Latest Information Update: 24 Mar 2018

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At a glance

  • Originator Genmab
  • Developer Genmab; GlaxoSmithKline; Mundipharma International; National Cancer Centre (Singapore); Novartis; Roswell Park Cancer Institute; University Health Network
  • Class Antibodies; Antineoplastics; Antirheumatics; Neuroprotectants; Skin disorder therapies
  • Mechanism of Action B cell inhibitors; Immunomodulators
  • Orphan Drug Status

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

    Yes - Chronic lymphocytic leukaemia
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Chronic lymphocytic leukaemia
  • Phase III B cell lymphoma; Diffuse large B cell lymphoma; Follicular lymphoma; Multiple sclerosis
  • Phase II Marginal-zone-B-cell-lymphoma; Precursor cell lymphoblastic leukaemia-lymphoma
  • Suspended Neuromyelitis optica
  • Discontinued Pemphigus vulgaris; Rheumatoid arthritis; Waldenstrom's macroglobulinaemia

Most Recent Events

  • 22 Jan 2018 Novartis intends to transition ofatumumab for Chronic lymphocytic leukaemia from commercial availability to limited availability through compassionate use programmes in all non-USA markets
  • 22 Jan 2018 Withdrawn for Chronic lymphocytic leukaemia (Second-line therapy or greater) in United Kingdom, Finland, Israel, Switzerland, Czech Republic, Sweden, Portugal, Poland, Netherlands, Ireland, Greece, Denmark, Austria, Germany, France, Japan, South America, Norway, Italy (IV)
  • 22 Jan 2018 Withdrawn for Chronic lymphocytic leukaemia in Russia (IV)
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