Ublituximab

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Ublituximab
Monoclonal antibody
Type Whole antibody
Source Chimeric (mouse/human)
Target CD20
Clinical data
Trade names Briumvi
Other namesublituximab-xiiy
AHFS/Drugs.com Monograph
MedlinePlus a623008
License data
Routes of
administration 		Intravenous
ATC code
Legal status
Legal status
Identifiers
CAS Number
DrugBank
ChemSpider
  • none
UNII
KEGG
Chemical and physical data
Formula C6418H9866N1702O2006S48
Molar mass 144504.31 g·mol−1
 X mark.svgNYes check.svgY  (what is this?)    (verify)

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]

Contents

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]

Related Research Articles

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References

  1. 1 2 3 4 5 "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.
  3. 1 2 3 "Briumvi EPAR". European Medicines Agency. 13 July 2023. Archived from the original on 14 July 2023. Retrieved 13 July 2023.
  4. 1 2 3 4 5 6 7 "FDA Roundup: December 30, 2022". U.S. Food and Drug Administration (FDA) (Press release). 30 December 2022. Retrieved 30 December 2022.PD-icon.svg 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.
  6. 1 2 "TG Therapeutics Announces FDA Approval of Briumvi (ublituximab-xiiy)" (Press release). TG Therapeutics. 28 December 2022. Retrieved 29 December 2022– via GlobeNewswire.
  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 .

Further reading


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