Ublituximab

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Ublituximab
Monoclonal antibody
TypeWhole antibody
SourceChimeric (mouse/human)
TargetCD20
Clinical data
Trade namesBriumvi
Other namesublituximab-xiiy
License data
Routes of
administration		Intravenous
ATC code
Legal status
Legal status
Identifiers
CAS Number
DrugBank
ChemSpider
  • none
UNII
KEGG
Chemical and physical data
FormulaC6418H9866N1702O2006S48
Molar mass144504.31 g·mol−1
 ☒NcheckY (what is this?)  (verify)

Ublituximab, sold under the brand name Briumvi, is an immunomodulator used for the treatment of multiple sclerosis.[1][2] 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.[2]

It was approved for medical use in the United States in December 2022.[1][3][4]

Medical uses

Ublituximab is indicated for the treatment of relapsing forms of multiple sclerosis.[1][2]

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.[2] Participants were randomized to receive either ublituximab or teriflunomide, the active comparator.[2] The primary outcome of both studies was the annualized relapse rate over the treatment period.[2] In both studies, ublituximab significantly lowered the annualized relapse rate compared to teriflunomide.[2]

Society and culture

Names

Ublituximab is the international nonproprietary name (INN).[5]

References

  1. ^ a b c d e "Briumvi- ublituximab injection, solution, concentrate". DailyMed. 19 January 2023. Retrieved 21 January 2023.
  2. ^ 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. Public Domain This article incorporates text from this source, which is in the public domain.
  3. ^ "Briumvi: FDA-Approved Drugs". U.S. Food and Drug Administration (FDA). Retrieved 29 December 2022.
  4. ^ "TG Therapeutics Announces FDA Approval of Briumvi (ublituximab-xiiy)" (Press release). TG Therapeutics. 28 December 2022. Retrieved 29 December 2022 – via GlobeNewswire.
  5. ^ 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

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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