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Ofatumumab - Genmab/GlaxoSmithKline/Novartis

Drug Profile

Ofatumumab - Genmab/GlaxoSmithKline/Novartis

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

Latest Information Update: 30 Jan 2019

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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 Antineoplastics; Antirheumatics; Monoclonal antibodies; Neuroprotectants; Skin disorder therapies
  • Mechanism of Action Antibody-dependent cell cytotoxicity; CD20 antigen inhibitors
  • 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

  • 28 Dec 2018 Novartis initiates enrolment in a phase III long-term safety trial for Multiple sclerosis in USA, Germany, Hungary, Slovakia, Austria, Sweden and Finland (EudraCT2017-004703-51) (NCT03650114)
  • 01 Dec 2018 Safety and efficacy data from the phase III COMPLEMENT A+B trial in B-cell lymphoma presented at the 60th Annual Meeting and Exposition of the American Society of Hematology (ASH-Hem-2018)
  • 18 Oct 2018 Novartis Pharmaceuticals initiates enrolment in a phase II trial for Mutliple sclerosis (Treatment-experienced) in the US and Estonia (NCT03560739) (EudraCT2017-004702-17)
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