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{{Short description|Chemical compound}}
{{Drugbox
{{Use dmy dates|date=December 2022}}
{{cs1 config |name-list-style=vanc |display-authors=6}}
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| type = mab
| type = mab
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<!-- Monoclonal antibody data -->
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| source = xi/o
| source = xi/o
| target = [[CD20]]
| target = [[CD20]]

<!--Clinical data -->
<!-- Clinical data -->
| tradename =
| Drugs.com =
| pronounce =
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| tradename = Briumvi
| Drugs.com = {{drugs.com|monograph|ublituximab}}
| MedlinePlus = a623008
| DailyMedID = Ublituximab
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| legal_US = Rx-only
| legal_US_comment = <ref name="Briumvi FDA label">{{cite web | title=Briumvi- ublituximab injection, solution, concentrate | website=DailyMed | date=19 January 2023 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3a77cd8c-811b-407c-9140-d0c5c26435c2 | access-date=21 January 2023 | archive-date=21 January 2023 | archive-url=https://web.archive.org/web/20230121044319/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3a77cd8c-811b-407c-9140-d0c5c26435c2 | url-status=live }}</ref>
| legal_EU = Rx-only
| legal_EU_comment = <ref>{{cite web | title=Briumvi | website=Union Register of medicinal products | date=1 June 2023 | 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 }}</ref><ref name="Briumvi EPAR">{{cite web | title=Briumvi EPAR | website=European Medicines Agency | date=13 July 2023 | 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 }}</ref>
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<!-- Identifiers -->
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| CAS_number = 1174014-05-1
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| synonyms = ublituximab-xiiy


<!-- Chemical and physical data -->
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| C = 6418 | H = 9866 | N = 1702 | O = 2006 | S = 48
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'''Ublituximab''', sold under the brand name '''Briumvi''', is an [[Immunotherapy#Immunomodulators|immunomodulator]] used for the treatment of [[multiple sclerosis]].<ref name="Briumvi FDA label" /><ref name="FDA PR 20221230" /> It is a [[CD20]]-directed cytolytic [[monoclonal antibody]].<ref name="Briumvi FDA label" />
'''Ublituximab''' is an [[Immunotherapy#Immunomodulators|immunomodulator]]. It binds to [[CD20]].<ref>{{cite journal | author = [[World Health Organization]] | title = International Nonproprietary Names for Pharmaceutical Substances (INN). Proposed INN: List 104 | journal = WHO Drug Information | volume = 24 | issue = 4 | year = 2010 | url =https://www.who.int/medicines/publications/druginformation/innlists/Final_PL104.pdf }}</ref>


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.<ref name="FDA PR 20221230">{{cite press release | title=FDA Roundup: December 30, 2022 | website=U.S. [[Food and Drug Administration]] (FDA) | date=30 December 2022 | url=https://www.fda.gov/news-events/press-announcements/fda-roundup-december-30-2022 | access-date=30 December 2022}} {{PD-notice}}</ref>
It is in [[phases of clinical research|Phase 3 clinical trials]] for [[multiple sclerosis]].<ref>{{ClinicalTrialsGov|NCT03277261|A Phase 3, Randomized, Multi-center, Double-blinded, Active-controlled Study to Assess the Efficacy and Safety/Tolerability of Ublituximab (TG-1101; UTX) as Compared to Teriflunomide in Subjects With Relapsing Multiple Sclerosis (RMS) (ULTIMATE 1)}}</ref>


It was approved for medical use in the United States in December 2022,<ref name="Briumvi FDA label" /><ref>{{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=live }}</ref><ref name=":0">{{cite press release | title=TG Therapeutics Announces FDA Approval of Briumvi (ublituximab-xiiy) | publisher=TG Therapeutics | via=GlobeNewswire | date=28 December 2022 | 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}}</ref><ref name="pmid36920653">{{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 }}</ref> and in the European Union in May 2023.<ref name="Briumvi EPAR" />
It is also in "U2" Phase 3 clinical trials for [[chronic lymphocytic leukemia]] in combination with [[Umbralisib]].<ref>{{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 }}</ref><ref>{{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 }}</ref>


==See also==
== Medical uses ==
Ublituximab is [[indicated]] for the treatment of relapsing-remitting, active secondary progressive, and clinically isolated syndrome forms of multiple sclerosis in adults.<ref name="Briumvi FDA label" /><ref name="FDA PR 20221230" /><ref name=":0" />
*[[Multiple sclerosis drug pipeline]]

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.<ref name="Briumvi EPAR" />

== 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.<ref name="FDA PR 20221230" /> Participants were randomized to receive either ublituximab or [[teriflunomide]], the active comparator.<ref name="FDA PR 20221230" /> The primary outcome of both studies was the annualized relapse rate over the treatment period.<ref name="FDA PR 20221230" /> In both studies, ublituximab significantly lowered the annualized relapse rate compared to teriflunomide.<ref name="FDA PR 20221230" />

== Society and culture ==
=== Names ===
Ublituximab is the [[international nonproprietary name]] (INN).<ref>{{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 }}</ref>


== References ==
== References ==
{{reflist}}
<references/>

== 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 }}
{{refend}}

== 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)}}


{{Immunosuppressants}}
{{monoclonals for tumors}}
{{Monoclonals for tumors}}
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{{Authority control}}


[[Category:Monoclonal antibodies]]
[[Category:Monoclonal antibodies]]
[[Category:Orphan drugs]]




Latest revision as of 04:53, 8 February 2024

Ublituximab
Monoclonal antibody
TypeWhole antibody
SourceChimeric (mouse/human)
TargetCD20
Clinical data
Trade namesBriumvi
Other namesublituximab-xiiy
AHFS/Drugs.comMonograph
MedlinePlusa623008
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][4] 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.[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[edit]

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[edit]

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[edit]

Names[edit]

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

References[edit]

  1. ^ a b c d e "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. ^ a b c "Briumvi EPAR". European Medicines Agency. 13 July 2023. Archived from the original on 14 July 2023. Retrieved 13 July 2023.
  4. ^ 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.
  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. ^ a b "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[edit]

External links[edit]

  • 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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