Ublituximab Explained

Verifiedfields:changed
Verifiedrevid:470619391
Type:mab
Mab Type:mab
Source:xi/o
Target:CD20
Tradename:Briumvi
Dailymedid:Ublituximab
Routes Of Administration:Intravenous
Atc Prefix:L04
Atc Suffix:AG14
Legal Us:Rx-only
Legal Us Comment:[1]
Legal Eu:Rx-only
Legal Eu Comment:[2] [3]
Cas Number:1174014-05-1
Drugbank:DB11850
Chemspiderid:none
Unii:U59UGK3IPC
Kegg:D11243
Synonyms:ublituximab-xiiy
C:6418
H:9866
N:1702
O:2006
S:48

Ublituximab, sold under the brand name Briumvi, is an immunomodulator used for the treatment of multiple sclerosis. It is a CD20-directed cytolytic monoclonal antibody.

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,[5] [6] [7] and in the European Union in May 2023.

Medical uses

Ublituximab is indicated for the treatment of relapsing-remitting, active secondary progressive, and clinically isolated syndrome forms of multiple sclerosis in adults.

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.

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

Society and culture

Names

Ublituximab is the international nonproprietary name (INN).[8]

Further reading

Notes and References

  1. Web site: Briumvi- ublituximab injection, solution, concentrate . DailyMed . 19 January 2023 . 21 January 2023 . 21 January 2023 . https://web.archive.org/web/20230121044319/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3a77cd8c-811b-407c-9140-d0c5c26435c2 . live .
  2. Web site: Briumvi . Union Register of medicinal products . 1 June 2023 . 6 June 2023 . 14 July 2023 . https://web.archive.org/web/20230714043733/https://ec.europa.eu/health/documents/community-register/html/h1730.htm . live .
  3. Web site: Briumvi EPAR . European Medicines Agency . 13 July 2023 . 13 July 2023 . 14 July 2023 . https://web.archive.org/web/20230714043732/https://www.ema.europa.eu/en/medicines/human/EPAR/briumvi . live .
  4. FDA Roundup: December 30, 2022 . U.S. Food and Drug Administration (FDA) . 30 December 2022 . 30 December 2022.
  5. Web site: Briumvi: FDA-Approved Drugs . U.S. Food and Drug Administration (FDA) . 29 December 2022 . 30 December 2022 . https://web.archive.org/web/20221230061810/https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761238 . live .
  6. TG Therapeutics Announces FDA Approval of Briumvi (ublituximab-xiiy) . TG Therapeutics . GlobeNewswire . 28 December 2022 . 29 December 2022.
  7. Lee A . Ublituximab: First Approval . Drugs . 83 . 5 . 455–459 . April 2023 . 36920653 . 10.1007/s40265-023-01854-z . 257534756 .
  8. ((World Health Organization)) . International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 66 . WHO Drug Information . 25 . 3 . 2011 . 10665/74683 . free . World Health Organization .

This article is licensed under the GNU Free Documentation License. It uses material from the Wikipedia article "Ublituximab".

Except where otherwise indicated, Everything.Explained.Today is © Copyright 2009-2024, A B Cryer, All Rights Reserved. Cookie policy.