Drug Profile

Ofatumumab - Genmab/Novartis

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

Latest Information Update: 19 Dec 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; CD20 antigen inhibitors; 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

04 Nov 2025 Novartis completes a phase III trial in Multiple sclerosis (Newly diagnosed) in France, Germany, Italy, Spain (SC) (NCT04788615)
24 Sep 2025 Updated efficacy, immunogenicity and adverse events data from the full 96-week phase IIIb ARTIOS trial in Multiple sclerosis presented at the 41^st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS-2025)
24 Sep 2025 Adverse events and efficacy data from the phase-III ALITHIOS trial in Multiple sclerosis released by Novartis

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