Ublituximab: Difference between revisions
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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" /> It is a [[CD20]]-directed cytolytic [[monoclonal antibody]].<ref name="Briumvi FDA label" /> |
'''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" /> |
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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> |
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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}}</ref><ref>{{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> |
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}}</ref><ref>{{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> |
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== Medical uses == |
== Medical uses == |
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Ublituximab is [[indicated]] for the treatment of relapsing forms of multiple sclerosis.<ref name="Briumvi FDA label" /> |
Ublituximab is [[indicated]] for the treatment of relapsing forms of multiple sclerosis.<ref name="Briumvi FDA label" /><ref name="FDA PR 20221230" /> |
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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" /> |
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== Society and culture == |
== Society and culture == |
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=== Names === |
=== Names === |
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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> |
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> |
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It is in [[phases of clinical research|phase III 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> |
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== References == |
== References == |
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{{reflist}} |
{{reflist}} |
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== Further reading == |
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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 }} |
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| ⚫ | * {{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}} |
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* {{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 }} |
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== External links == |
== External links == |
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Revision as of 00:50, 31 December 2022
| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Chimeric (mouse/human) |
| Target | CD20 |
| Clinical data | |
| Trade names | Briumvi |
| Other names | ublituximab-xiiy |
| License data |
|
| Routes of administration | Intravenous |
| ATC code |
|
| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| DrugBank | |
| ChemSpider |
|
| UNII | |
| KEGG | |
| Chemical and physical data | |
| Formula | C6418H9866N1702O2006S48 |
| Molar mass | 144504.31 g·mol−1 |
  (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
- ^ a b c d e https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761238s000lbl.pdf
- ^ 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.
Further reading
- Babiker HM, Glode AE, Cooke LS, Mahadevan D (April 2018). "Ublituximab for the treatment of CD20 positive B-cell malignancies". Expert Opinion on Investigational Drugs. 27 (4): 407–412. doi:10.1080/13543784.2018.1459560. PMID 29609506. S2CID 4775126.
- Lunning M, Vose J, Nastoupil L, Fowler N, Burger JA, Wierda WG, et al. (November 2019). "Ublituximab and umbralisib in relapsed/refractory B-cell non-Hodgkin lymphoma and chronic lymphocytic leukemia". Blood. 134 (21): 1811–1820. doi:10.1182/blood.2019002118. PMC 7042665. PMID 31558467.
- Steinman L, Fox E, Hartung HP, Alvarez E, Qian P, Wray S, et al. (August 2022). "Ublituximab versus Teriflunomide in Relapsing Multiple Sclerosis". The New England Journal of Medicine. 387 (8): 704–714. doi:10.1056/NEJMoa2201904. PMID 36001711.
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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