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
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Ublituximab, sold under the brand name Briumvi, is an immunomodulator used for the treatment of multiple sclerosis.^[1]^[4] 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,^[1]^[5]^[6]^[7] and in the European Union in May 2023.^[3]

Medical uses

Ublituximab is indicated for the treatment of relapsing-remitting, active secondary progressive, and clinically isolated syndrome forms of multiple sclerosis in adults.^[1]^[4]^[6]

In the European Union, ublituximab is indicated for the treatment of adults with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features.^[3]

History

Researchers demonstrated the efficacy of ublituximab in two randomized, double-blind, double-dummy, parallel group, active comparator-controlled clinical trials of identical design, in participants with relapsing forms of multiple sclerosis treated for 96 weeks.^[4] Participants were randomized to receive either ublituximab or teriflunomide, the active comparator.^[4] The primary outcome of both studies was the annualized relapse rate over the treatment period.^[4] In both studies, ublituximab significantly lowered the annualized relapse rate compared to teriflunomide.^[4]

Society and culture

Names

Ublituximab is the international nonproprietary name (INN).^[8]

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.
^ "Briumvi". Union Register of medicinal products. 1 June 2023. Archived from the original on 14 July 2023. Retrieved 6 June 2023.
^ ^a ^b ^c "Briumvi EPAR". European Medicines Agency. 13 July 2023. Archived from the original on 14 July 2023. Retrieved 13 July 2023.
^ ^a ^b ^c ^d ^e ^f ^g "FDA Roundup: December 30, 2022". U.S. Food and Drug Administration (FDA) (Press release). 30 December 2022. Retrieved 30 December 2022. This article incorporates text from this source, which is in the public domain.
^ "Briumvi: FDA-Approved Drugs". U.S. Food and Drug Administration (FDA). Archived from the original on 30 December 2022. Retrieved 29 December 2022.
^ ^a ^b "TG Therapeutics Announces FDA Approval of Briumvi (ublituximab-xiiy)" (Press release). TG Therapeutics. 28 December 2022. Retrieved 29 December 2022 – via GlobeNewswire.
^ Lee A (April 2023). "Ublituximab: First Approval". Drugs. 83 (5): 455–459. doi:10.1007/s40265-023-01854-z. PMID 36920653. S2CID 257534756.
^ 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

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[Briumvi_FDA_label-1] "Briumvi- ublituximab injection, solution, concentrate". DailyMed. 19 January 2023. Archived from the original on 21 January 2023. Retrieved 21 January 2023.

[2] "Briumvi". Union Register of medicinal products. 1 June 2023. Archived from the original on 14 July 2023. Retrieved 6 June 2023.

[Briumvi_EPAR-3] "Briumvi EPAR". European Medicines Agency. 13 July 2023. Archived from the original on 14 July 2023. Retrieved 13 July 2023.

[FDA_PR_20221230-4] ^ ^a ^b ^c ^d ^e ^f ^g "FDA Roundup: December 30, 2022". U.S. Food and Drug Administration (FDA) (Press release). 30 December 2022. Retrieved 30 December 2022. This article incorporates text from this source, which is in the public domain.

[5] "Briumvi: FDA-Approved Drugs". U.S. Food and Drug Administration (FDA). Archived from the original on 30 December 2022. Retrieved 29 December 2022.

[:0-6] "TG Therapeutics Announces FDA Approval of Briumvi (ublituximab-xiiy)" (Press release). TG Therapeutics. 28 December 2022. Retrieved 29 December 2022 – via GlobeNewswire.

[pmid36920653-7] Lee A (April 2023). "Ublituximab: First Approval". Drugs. 83 (5): 455–459. doi:10.1007/s40265-023-01854-z. PMID 36920653. S2CID 257534756.

[8] World Health Organization (2011). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 66". WHO Drug Information. 25 (3). hdl:10665/74683.

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