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 |
|
Routes of administration | Intravenous |
ATC code | |
Legal status | |
Legal status | |
Identifiers | |
CAS Number | |
DrugBank | |
ChemSpider |
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UNII | |
KEGG | |
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]
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]
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]
Ublituximab is the international nonproprietary name (INN). [8]