Ublituximab

Ublituximab
Monoclonal antibody
Type	Whole antibody
Source	Chimeric (mouse/human)
Target	CD20
Clinical data
Trade names	Briumvi
Other names	ublituximab-xiiy
AHFS/Drugs.com	Monograph
MedlinePlus	a623008
License data	US DailyMed: Ublituximab;
Routes of; administration	Intravenous
ATC code	L04AG14 (WHO) ;
Legal status
Legal status	US: ℞-only; EU: Rx-only;
Identifiers
CAS Number	1174014-05-1;
DrugBank	DB11850;
ChemSpider	none;
UNII	U59UGK3IPC;
KEGG	D11243;
Chemical and physical data
Formula	C6418H9866N1702O2006S48
Molar mass	144504.31 g·mol−1

Ublituximab, sold under the brand name Briumvi, is an immunomodulator used for the treatment of multiple sclerosis.^[1] It is a CD20-directed cytolytic monoclonal antibody.^[1]

The most common adverse reactions include infusion reactions, including fever, chills, headache, influenza-like illness, elevated heart rate, nausea, throat irritation, reddening of the skin (erythema) and an anaphylactic (allergic) reaction; infections including serious and fatal bacterial, fungal, and new or reactivated viral infections and reduction in immunoglobulins.^[4]

It was approved for medical use in the United States in December 2022,^[5]^[6] and in the European Union in May 2023.^[2]

Medical uses

Ublituximab is indicated for the treatment of relapsing forms of multiple sclerosis.^[1]^[2]

History

Ublituximab was designed as part of a research program by the French Laboratory of Fractionation and Biotechnology, with the initial objective of addressing a clinical need in chronic B-lymphocytic leukemia.^[7] The design of ublituximab has been optimized to enhance the activation of killer immune cells while minimizing side effects, through modifications to its structure and glycosylation.^[8] After clinical trials confirming its strong cytotoxic activity and ability to eliminate B cells, the development of ublituximab was pursued by the American biopharmaceutical company TG Therapeutics.

The US Food and Drug Administration approved ublituximab based on evidence from two clinical trials of 1,093 participants with relapsing forms of multiple sclerosis.^[4] The trials were conducted at 110 of sites in 10 countries in North America and Europe.^[4] The trials were used to assess both efficacy and safety of ublituximab.^[4] Participants received ublituximab or teriflunomide for up to 96 weeks.^[4] Neither the participants nor the health care providers knew which treatment was being given until the trials were completed.^[4] The benefit of ublituximab was evaluated based on the annualized relapse rate, or the number of relapses per year, over the treatment period.^[4]

Society and culture

Legal status

Ublituximab was approved for medical use in the United States in December 2022,^[1]^[9] and in the European Union in May 2023.^[2]^[3]

Names

Ublituximab is the international nonproprietary name (INN).^[10]

Ublituximab is sold under the brand name Briumvi.^[2]

References

^ ^a ^b ^c ^d ^e "Briumvi- ublituximab injection, solution, concentrate". DailyMed. 19 January 2023. Archived from the original on 21 January 2023. Retrieved 21 January 2023.
^ ^a ^b ^c ^d ^e "Briumvi EPAR". European Medicines Agency. 13 July 2023. Archived from the original on 14 July 2023. Retrieved 13 July 2023.
^ ^a ^b "Briumvi". Union Register of medicinal products. 1 June 2023. Archived from the original on 14 July 2023. Retrieved 6 June 2023.
^ ^a ^b ^c ^d ^e ^f ^g "Drug Trials Snapshots: Briumvi". U.S. Food and Drug Administration (FDA). 28 December 2022. Retrieved 25 August 2025. This article incorporates text from this source, which is in the public domain.
^ "Drug Approval Package: Briumvi". U.S. Food and Drug Administration (FDA). 6 February 2023. Retrieved 25 August 2025.
^ Lee A (April 2023). "Ublituximab: First Approval". Drugs. 83 (5): 455–459. doi:10.1007/s40265-023-01854-z. PMID 36920653. S2CID 257534756.
^ Romeuf C, Dutertre CA, Garff-Tavernier M, Fournier N, Gaucher C, Glacet A, et al. (March 2008). "Chronic lymphocytic leukaemia cells are efficiently killed by an anti-CD20 monoclonal antibody selected for improved engagement of FcgammaRIIIA/CD16". British Journal of Haematology. 140 (6): 635–643. doi:10.1111/j.1365-2141.2007.06974.x. ISSN 1365-2141. PMID 18302712.
^ de Romeuf C (1 December 2019). "EMABling, une technologie stimulant l'activité effectrice des anticorps monoclonaux - Histoire et applications cliniques vingt ans après" [EMABling, a technology boosting the effector function of monoclonal antibodies: history and clinical applications twenty years after the discovery]. Médecine/Sciences (in French). 35 (12): 1160–1162. doi:10.1051/medsci/2019220. ISSN 0767-0974. PMID 31903931.
^ "TG Therapeutics Announces FDA Approval of Briumvi (ublituximab-xiiy)" (Press release). TG Therapeutics. 28 December 2022. Retrieved 29 December 2022 – via GlobeNewswire.
^ World Health Organization (2011). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 66". WHO Drug Information. 25 (3). hdl:10665/74683.

External links

Clinical trial number NCT03277261 for "Study to Assess the Efficacy and Safety of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis (RMS) (ULTIMATE 1)" at ClinicalTrials.gov
Clinical trial number NCT03277248 for "Study to Assess the Efficacy and Safety of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis (RMS) (ULTIMATE II)" at ClinicalTrials.gov