Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Review
. 2023 Apr;83(5):455-459.
doi: 10.1007/s40265-023-01854-z.

Ublituximab: First Approval

Arnold Lee  1
Affiliations
Review

Ublituximab: First Approval

Arnold Lee. Drugs. 2023 Apr.

Abstract

Ublituximab (ublituximab-xiiy; BRIUMVI™) is a glycoengineered anti-CD20 monoclonal antibody developed by TG Therapeutics, Inc. for the treatment of multiple sclerosis (MS). The mechanism of action of ublituximab involves the depletion of B cells via antibody-dependent cellular cytotoxicity, as B cells have a key role in the pathogenesis of MS. Ublituximab is the first anti-CD20 treatment that is administered twice-yearly as one hour infusions, following the initial doses. In December 2022, ublituximab received its first global approval in the USA for the treatment of adults with relapsing forms of MS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. This article summarizes the milestones in the development of ublituximab leading to this first approval in this indication.

PubMed Disclaimer

Similar articles

See all similar articles

Cited by

See all "Cited by" articles

References

    1. Margoni M, Preziosa P, Filippi M, et al. Anti-CD20 therapies for multiple sclerosis: current status and future perspectives. J Neurol. 2022;269(3):1316–34. - DOI - PubMed
    1. TG Therapeutics Inc. TG Therapeutics announces FDA approval of BRIUMVI™ (ublituximab-xiiy) [media release]. 28 Dec 2022. https://ir.tgtherapeutics.com/ .
    1. TG Therapeutics Inc. BRIUMVI™ (ublituximab-xiiy): US prescribing information. 2022. https://dailymed.nlm.nih.gov/ . Accessed 22 Feb 2023.
    1. TG Therapeutics Inc. TG Therapeutics completes licensing agreement with LFB Biotechnologies for the development of ublituximab [media release]. 2 Mar 2012. http://www.tgtherapeutics.com .
    1. T. G. Therapeutics Inc. TG Therapeutics announces exclusive licensing agreement with Ildong Pharmaceutical Co., Ltd. for development and commercialization of ublituximab (TGTX-1101) in South Korea and Southeast Asia [media release]. 15 Nov 2012.

MeSH terms

LinkOut - more resources