Ublituximab: Difference between revisions

Ublituximab
Monoclonal antibody
Type	Whole antibody
Source	Chimeric (mouse/human)
Target	CD20
Clinical data
Trade names	Briumvi
Other names	ublituximab-xiiy
License data	US DailyMed: Ublituximab;
Routes of; administration	Intravenous
ATC code	L04AA57 (WHO) ;
Legal status
Legal status	US: ℞-only;
Identifiers
CAS Number	1174014-05-1 ;
DrugBank	DB11850;
ChemSpider	none;
UNII	U59UGK3IPC;
KEGG	D11243;
Chemical and physical data
Formula	C6418H9866N1702O2006S48
Molar mass	144504.31 g·mol−1
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Revision as of 02:49, 25 January 2023

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

^ ^a ^b ^c ^d ^e "Briumvi- ublituximab injection, solution, concentrate". DailyMed. 19 January 2023. Retrieved 21 January 2023.
^ ^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. This article incorporates text from this source, which is in the public domain.
^ "Briumvi: FDA-Approved Drugs". U.S. Food and Drug Administration (FDA). Retrieved 29 December 2022.
^ "TG Therapeutics Announces FDA Approval of Briumvi (ublituximab-xiiy)" (Press release). TG Therapeutics. 28 December 2022. Retrieved 29 December 2022 – via GlobeNewswire.
^ World Health Organization (2011). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 66". WHO Drug Information. 25 (3). hdl:10665/74683.

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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[Briumvi_FDA_label-1] "Briumvi- ublituximab injection, solution, concentrate". DailyMed. 19 January 2023. Retrieved 21 January 2023.

[FDA_PR_20221230-2] ^ ^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. 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.

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 * {{cite journal | vauthors = Babiker HM, Glode AE, Cooke LS, Mahadevan D | title = Ublituximab for the treatment of CD20 positive B-cell malignancies | journal = Expert Opinion on Investigational Drugs | volume = 27 | issue = 4 | pages = 407–412 | date = April 2018 | pmid = 29609506 | doi = 10.1080/13543784.2018.1459560 | s2cid = 4775126 }}
 * {{cite journal | vauthors = Lunning M, Vose J, Nastoupil L, Fowler N, Burger JA, Wierda WG, Schreeder MT, Siddiqi T, Flowers CR, Cohen JB, Sportelli P, Miskin HP, Weiss MS, O'Brien S | display-authors = 6 | title = Ublituximab and umbralisib in relapsed/refractory B-cell non-Hodgkin lymphoma and chronic lymphocytic leukemia | journal = Blood | volume = 134 | issue = 21 | pages = 1811–1820 | date = November 2019 | pmid = 31558467 | pmc = 7042665 | doi = 10.1182/blood.2019002118 | doi-access = free | title-link = doi}}
-* {{cite journal | vauthors = Steinman L, Fox E, Hartung HP, Alvarez E, Qian P, Wray S, Robertson D, Huang D, Selmaj K, Wynn D, Cutter G, Mok K, Hsu Y, Xu Y, Weiss MS, Bosco JA, Power SA, Lee L, Miskin HP, Cree BA | display-authors = 6 | title = Ublituximab versus Teriflunomide in Relapsing Multiple Sclerosis | journal = The New England Journal of Medicine | volume = 387 | issue = 8 | pages = 704–714 | date = August 2022 | pmid = 36001711 | doi = 10.1056/NEJMoa2201904 }}
+* {{cite journal | vauthors = Steinman L, Fox E, Hartung HP, Alvarez E, Qian P, Wray S, Robertson D, Huang D, Selmaj K, Wynn D, Cutter G, Mok K, Hsu Y, Xu Y, Weiss MS, Bosco JA, Power SA, Lee L, Miskin HP, Cree BA | display-authors = 6 | title = Ublituximab versus Teriflunomide in Relapsing Multiple Sclerosis | journal = The New England Journal of Medicine | volume = 387 | issue = 8 | pages = 704–714 | date = August 2022 | pmid = 36001711 | doi = 10.1056/NEJMoa2201904 | s2cid = 251808946 }}
 == External links ==