Drug Profile

Ofatumumab - Genmab/Novartis

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

Latest Information Update: 19 Mar 2025

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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; Eye disorder therapies; Immunotherapies; Monoclonal antibodies; Neuroprotectants; Skin disorder therapies
Mechanism of Action Antibody-dependent cell cytotoxicity; T lymphocyte stimulants

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

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

12 Mar 2025 Novartis Pharmaceuticals plans a phase III FILIOS trial for Multiple Sclerosis in March 2025 (Parenteral) (NCT06869785)
11 Mar 2025 Novartis completes the phase III ARTIOS trial for Multiple Sclerosis (Treatment-experienced) in the US, Germany, Greece, Hungary, Belgium, Portugal, Bulgaria, Spain, Argentina, Australia, Austria, Canada, Czech republic, Estonia, Italy, Latvia, Lebanon, Mexico, Norway, Poland, Russia, Saudi Arabia, Slovakia, Slovenia, Switzerland, Turkey, United Kingdom (IV) (NCT04353492) (EudraCT2019-001341-40)
18 Sep 2024 Updated efficacy and adverse events data from the phase III OLIKOS open-label extension trial in Multiple sclerosis presented at the 40th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS-2024)

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