ublituximab
{{Short description|Chemical compound}}
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| verifiedrevid = 470619391
| type = mab
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| mab_type = mab
| source = xi/o
| target = CD20
| pronounce =
| tradename = Briumvi
| Drugs.com = {{drugs.com|monograph|ublituximab}}
| MedlinePlus = a623008
| DailyMedID = Ublituximab
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| routes_of_administration = Intravenous
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| ATC_prefix = L04
| ATC_suffix = AG14
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| legal_US = Rx-only
| legal_EU = Rx-only
| legal_EU_comment = {{cite web | title = Briumvi | date = 1 June 2023 | website = Union Register of medicinal products | url = https://ec.europa.eu/health/documents/community-register/html/h1730.htm | access-date = 6 June 2023 | archive-date = 14 July 2023 | archive-url = https://web.archive.org/web/20230714043733/https://ec.europa.eu/health/documents/community-register/html/h1730.htm | url-status = live }}{{cite web | title = Briumvi EPAR | date = 13 July 2023 | website = European Medicines Agency | url = https://www.ema.europa.eu/en/medicines/human/EPAR/briumvi | access-date = 13 July 2023 | archive-date = 14 July 2023 | archive-url = https://web.archive.org/web/20230714043732/https://www.ema.europa.eu/en/medicines/human/EPAR/briumvi | url-status = live }}
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| CAS_number = 1174014-05-1
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| DrugBank = DB11850
| ChemSpiderID_Ref = {{chemspidercite|changed|chemspider}}
| ChemSpiderID = none
| UNII_Ref = {{fdacite|correct|FDA}}
| UNII = U59UGK3IPC
| KEGG = D11243
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| synonyms = ublituximab-xiiy
| IUPAC_name =
| C = 6418 | H = 9866 | N = 1702 | O = 2006 | S = 48
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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.{{cite press release | title = FDA Roundup: December 30, 2022 | date = 30 December 2022 | website = U.S. Food and Drug Administration (FDA) | url = https://www.fda.gov/news-events/press-announcements/fda-roundup-december-30-2022 | access-date = 30 December 2022 }}{{dead link|date=May 2025|bot=medic}}{{cbignore|bot=medic}} {{PD-notice}}
It was approved for medical use in the United States in December 2022,{{cite web | title = Briumvi: FDA-Approved Drugs | publisher = U.S. Food and Drug Administration (FDA) | url = https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761238 | access-date = 29 December 2022 | archive-date = 30 December 2022 | archive-url = https://web.archive.org/web/20221230061810/https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761238 | url-status = dead }}{{cite press release | title = TG Therapeutics Announces FDA Approval of Briumvi (ublituximab-xiiy) | date = 28 December 2022 | publisher = TG Therapeutics | via = GlobeNewswire | url = https://www.globenewswire.com/news-release/2022/12/28/2580377/8790/en/TG-Therapeutics-Announces-FDA-Approval-of-BRIUMVI-ublituximab-xiiy.html | access-date = 29 December 2022 }}{{cite journal | vauthors = Lee A | title = Ublituximab: First Approval | journal = Drugs | volume = 83 | issue = 5 | pages = 455–459 | date = April 2023 | pmid = 36920653 | doi = 10.1007/s40265-023-01854-z | s2cid = 257534756 | url = https://figshare.com/articles/online_resource/Ublituximab_First_Approval/22138283 }} 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
Ublituximab was designed as part of a research program initiated more than fifteen years ago by the French Laboratory of Fractionation and Biotechnology (LFB), with the initial objective of addressing a clinical need in chronic B-lymphocytic leukemia (B-CLL).{{cite journal | vauthors = Romeuf C, Dutertre CA, Garff-Tavernier M, Fournier N, Gaucher C, Glacet A, Jorieux S, Bihoreau N, Behrens CK, Beliard R, Vieillard V, Cazin B, Bourel D, Prost JF, Teillaud JL, Merle-Beral H | title = Chronic lymphocytic leukaemia cells are efficiently killed by an anti-CD20 monoclonal antibody selected for improved engagement of FcgammaRIIIA/CD16 | journal = British Journal of Haematology | volume = 140 | issue = 6 | pages = 635–643 | date = March 2008 | pmid = 18302712 | doi = 10.1111/j.1365-2141.2007.06974.x | issn = 1365-2141 }} The design of ublituximab has been optimized to enhance the activation of killer immune cells while minimizing side effects, through modifications to its structure and glycosylation.{{cite journal | vauthors = de Romeuf C | title = EMABling®, une technologie stimulant l’activité effectrice des anticorps monoclonaux - Histoire et applications cliniques vingt ans après | journal = Médecine/Sciences | volume = 35 | issue = 12 | pages = 1160–1162 | date = 1 December 2019 | pmid = 31903931 | doi = 10.1051/medsci/2019220 | url = https://www.medecinesciences.org/en/articles/medsci/full_html/2019/12/msc190244/msc190244.html | language = fr | issn = 0767-0974 | url-access = subscription }} After initial clinical trials confirming its strong cytotoxic activity and ability to eliminate B cells, the development of ublituximab was pursued by the American biopharmaceutical company TG Therapeutics, which then marketed it under the name Briumvi. 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).{{cite journal | vauthors = ((World Health Organization)) | title = International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 66 | journal = WHO Drug Information | volume = 25 | issue = 3 | year = 2011 | hdl = 10665/74683 | hdl-access = free | author-link = World Health Organization }}
References
{{Reflist}}
Further reading
{{refbegin}}
- {{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 | 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 | 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 | doi-access = free }}
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External links
- {{ClinicalTrialsGov|NCT03277261|Study to Assess the Efficacy and Safety of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis (RMS) (ULTIMATE 1)}}
- {{ClinicalTrialsGov|NCT03277248|Study to Assess the Efficacy and Safety of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis (RMS) (ULTIMATE II)}}
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Category:Monoclonal antibodies
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