Ofatumumab

Drug Profile

Ofatumumab

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

Latest Information Update: 30 Dec 2016

Price : $50

At a glance

  • Originator Genmab
  • Developer Genmab; GlaxoSmithKline; National Cancer Centre (Singapore); Novartis; Roswell Park Cancer Institute; University Health Network
  • Class Antineoplastics; Antirheumatics; Monoclonal antibodies; Skin disorder therapies
  • Mechanism of Action CD20 antigen inhibitors; Immunosuppressants
  • Orphan Drug Status

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

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

Most Recent Events

  • 12 Dec 2016 Registered for Chronic lymphocytic leukaemia (Second-line therapy or greater, Combination therapy) in Liechtenstein, Iceland, European Union, Norway (IV)
  • 10 Nov 2016 The Committee for Medicinal Products for Human Use (CHMP) recommends approval of ofatumumab for Chronic lymphocytic leukaemia (Second line therapy, Combination therapy) in European Union
  • 08 Nov 2016 Regulatory submission withdrawn for Chronic lymphocytic leukaemia (Combination therapy with bendamustine, Second-line therapy or greater) in European Union (PO) ,
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