Ublituximab

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]

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[1] EU: Rx-only[2][3]
Identifiers
CAS Number	1174014-05-1 Y
DrugBank	DB11850
ChemSpider	none
UNII	U59UGK3IPC
KEGG	D11243
Chemical and physical data
Formula	C6418H9866N1702O2006S48
Molar mass	144504.31 g·mol−1
NY (what is this?)  (verify)

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

Ublituximab was designed as part of a research program initiated more than fifteen years ago by the French Laboratory of Fractionation and Biotechnology (LFB), with the initial objective of addressing a clinical need in chronic B-lymphocytic leukemia (B-CLL).^[8] 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.^[9] After initial 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, which then marketed it under the name Briumvi. 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).^[10]