Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 66 |
| INN | Ofatumumab |
| Status | Approved |
| Drug code(s) | HuMAX-CD20, OMB157 |
| Brand name | ARZERRA, Kesimpta |
| mAb sequence source | mAb human |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | Transgenic mouse (GenPharm/Medarex/BMS transgenic mouse platform Ultimab) |
| Target(s) | CD20 |
| Indications of clinical studies | Chronic Lymphocytic Leukemia, Waldenstrom Macroglobulinaemia, rheumatoid arthritis, large-cell diffuse lymphoma, follicular lymphoma, multiple sclerosis |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Approved EU, US, Japan, Australia |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | November 15, 2003 |
| Start of Phase 2 | August 15, 2005 |
| Start of Phase 3 | May 15, 2006 |
| Date BLA/NDA submitted to FDA | January 30, 2009 |
| Year of first approval (global) | 2009 |
| Date of first US approval | October 26, 2009 |
| INN, US product name | Ofatumumab |
| US or EU approved indications | Chronic Lymphocytic Leukemia (in combination with chlorambucil, for the treatment of previously untreated patients with CLL for whom fludarabine-based therapy is considered inappropriate; in combination with fludarabine and cyclophosphamide for the treatment of patients with relapsed CLL; for extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive CLL; for the treatment of patients with CLL refractory to fludarabine and alemtuzumab). Marketed as Kesimpta in the EU and US as a medicine for treating adults with relapsing forms of multiple sclerosis |
| Company | Genmab |
| Licensee/Partner | GlaxoSmithKline, Novartis |
| Comments about company or candidate | Approved for r/r MS in the US on Aug 20, 2020 and in the EU on March 26, 2021. On 28 February 2019, the European Commission withdrew the marketing authorisation for Arzerra (ofatumumab) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Novartis Europharm Limited, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. Arzerra was granted marketing authorisation in the EU on 19 April 2010 for the treatment of chronic lymphocytic leukaemia. January 22, 2018 — Genmab A/S announced today that Novartis (SIX Swiss Exchange: NOVN) intends to transition Arzerra® (ofatumumab) for the treatment of certain chronic lymphocytic leukemia (CLL) indications from commercial availability to limited availability via compassionate use programs in all markets around the world except the United States. Novartis' intention to transition Arzerra to compassionate use programs in the non-US markets reflects the fact that many more drugs have become available for CLL over the last five years and that there is a low number of patients using Arzerra outside of the US market. The compassionate use programs will ensure that patients who benefit from Arzerra. Glaxosmithkline plc (GSK) sold the rights to Arzerra (ofatumumab) in autoimmune diseases for $1.034 billion to Novartis AG. Novartis previously acquired rights to Arzerra in cancer as part of a major transaction in which GSK sold its oncology business to the Swiss pharma for $16 billion. Fast track designation |
| Full address of company | Copenhagen, Denmark Europe Denmark https://www.genmab.com/ |
Kesimpta is the brand name for SC formulation for MS.
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |