Ublituximab

Ublituximab
Monoclonal antibody
Type	Whole antibody
Source	Chimeric (mouse/human)
Target	CD20
Clinical data
Trade names	Briumvi
Other names	ublituximab-xiiy
AHFS/Drugs.com	Monograph
MedlinePlus	a623008
License data	US DailyMed: Ublituximab
Routes of administration	Intravenous
ATC code	L04AG14 (WHO)
Legal status
Legal status	US: ℞-only^[1] EU: Rx-only^[2]^[3]
Identifiers
CAS Number	1174014-05-1^Y
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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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]

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Medical uses

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

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

Names

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

References

^ ^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.
^ "Briumvi". Union Register of medicinal products. 1 June 2023. Archived from the original on 14 July 2023. Retrieved 6 June 2023.
^ ^a ^b ^c "Briumvi EPAR". European Medicines Agency. 13 July 2023. Archived from the original on 14 July 2023. Retrieved 13 July 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). Archived from the original on 30 December 2022. Retrieved 29 December 2022.
^ ^a ^b "TG Therapeutics Announces FDA Approval of Briumvi (ublituximab-xiiy)" (Press release). TG Therapeutics. 28 December 2022. Retrieved 29 December 2022 – via GlobeNewswire.
^ Lee A (April 2023). "Ublituximab: First Approval". Drugs. 83 (5): 455–459. doi:10.1007/s40265-023-01854-z. PMID 36920653. S2CID 257534756.
^ 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

Immunosuppressive drugs / Immunosuppressants (L04)

Intracellular
(initiation)

Antimetabolites	purine synthesis inhibitors Azathioprine Mycophenolic acid dihydroorotate dehydrogenase inhibitors Leflunomide Teriflunomide antifolate Methotrexate
Macrolides/ other IL-2 inhibitors	FKBP/Cyclophilin/Calcineurin Ciclosporin Pimecrolimus Tacrolimus Voclosporin Abetimus Gusperimus
IMiDs	Lenalidomide Pomalidomide Thalidomide PDE4 inhibitor Apremilast

Intracellular
(reception)

IL-1 receptor antagonists	Anakinra
mTOR	Sirolimus Everolimus Ridaforolimus Temsirolimus Umirolimus Zotarolimus

Extracellular

Antibodies

Monoclonal

Serum target (noncellular)	Complement component 5 Eculizumab TNF Adalimumab Afelimomab Certolizumab pegol Golimumab Infliximab Nerelimomab Interleukin Anakinra Basiliximab Bimekizumab Briakinumab Brodalumab Canakinumab Daclizumab Guselkumab Ixekizumab Netakimab Olokizumab Rilonacept Risankizumab Sarilumab Satralizumab Secukinumab Siltuximab Sirukumab Spesolimab Tildrakizumab Tocilizumab Ustekinumab Interleukin 5 Mepolizumab Immunoglobulin E Omalizumab Interferon Faralimomab IL-6 Elsilimomab IL-12 and IL-23 Lebrikizumab Ustekinumab IL-17A Secukinumab
Cellular target	CD3 Muromonab-CD3 Otelixizumab Teplizumab Visilizumab CD4 Clenoliximab Keliximab Zanolimumab CD11a Efalizumab CD18 Erlizumab CD20 Obinutuzumab Ocrelizumab Pascolizumab Rituximab Ublituximab CD23 Gomiliximab Lumiliximab CD40 Teneliximab Toralizumab CD62L/L-selectin Aselizumab CD80 Galiximab CD147/Basigin Gavilimomab CD154 Ruplizumab Frexalimab BLyS Belimumab CAT Bertilimumab Lerdelimumab Metelimumab Integrin Natalizumab Vedolizumab Interleukin-6 receptor Tocilizumab LFA-1 Odulimomab IL-2 receptor/CD25 Basiliximab Daclizumab Inolimomab T-lymphocyte (Zolimomab aritox)
Unsorted	Alemtuzumab Anifrolumab Atorolimumab Begelomab Cedelizumab Emapalumab Fontolizumab Inebilizumab Maslimomab Morolimumab Ofatumumab Pexelizumab Reslizumab Rovelizumab Siplizumab Talizumab Telimomab aritox Teprotumumab Vapaliximab Vepalimomab

Polyclonal

-cept (Fusion)

CTLA-4
- Abatacept
- Belatacept
TNF inhibitor
- Etanercept
- Opinercept
Aflibercept
Alefacept
Rilonacept

Unsorted

Monoclonal antibodies for tumors

Tumor

Human	Adecatumumab^§ Amivantamab Ascrinvacumab^§ Atezolizumab Balstilimab^† Botensilimab Cixutumumab^§ Conatumumab^§ Daratumumab Drozitumab^§ Duligotumab^§ Dusigitumab^§ Enfortumab vedotin Enoticumab^§ Figitumumab^§ Flanvotumab^§ Ganitumab^† Glembatumumab vedotin^† Intetumumab^§ Ipilimumab Iratumumab^§ Istiratumab Icrucumab^§ Lexatumumab^§ Lucatumumab^§ Mapatumumab^§ Narnatumab^§ Necitumumab Nesvacumab^§ Nivolumab^# Ofatumumab Olaratumab^† Panitumumab Patritumab^§ Pembrolizumab^# Pritumumab^§ Radretumab^§ Ramucirumab Rilotumumab^† Robatumumab^§ Seribantumab^§ Tarextumab^§ Tisotumab vedotin Teprotumumab^† Tovetumab^§ Vantictumab^§ Votumumab^§ Zalutumumab^†
Mouse	Abagovomab Altumomab pentetate Anatumomab mafenatox Arcitumomab Bectumomab Blinatumomab Capromab pendetide Detumomab Edrecolomab Ibritumomab tiuxetan Igovomab Lilotomab Minretumomab Mitumomab Nacolomab tafenatox Moxetumomab pasudotox Naptumomab estafenatox Oregovomab Pemtumomab^† Racotumomab Satumomab pendetide Solitomab Taplitumomab paptox Nofetumomab merpentan Pintumomab Tenatumomab Tositumomab
Chimeric	Amatuximab^§ Bavituximab^§ Brentuximab vedotin Carotuximab^† Cetuximab Derlotuximab biotin^§ Dinutuximab Ecromeximab^§ Ensituximab^§ Futuximab^§ Girentuximab^† Indatuximab ravtansine^§ Isatuximab Loncastuximab tesirine Margetuximab Mirvetuximab soravtansine Rituximab^# Siltuximab Ublituximab
Humanized	Abituzumab^§ Alemtuzumab Belantamab mafodotin Bevacizumab Bivatuzumab mertansine^§ Brontictuzumab^§ Cantuzumab mertansine^§ Cantuzumab ravtansine^§ Cirmtuzumab Citatuzumab bogatox^§ Clivatuzumab tetraxetan Cofetuzumab pelidotin Dacetuzumab^§ Demcizumab^§ Dalotuzumab^§ Denintuzumab mafodotin^§ Elotuzumab Emactuzumab Emibetuzumab^§ Enoblituzumab^§ Epcoritamab Etaracizumab^§ Farletuzumab^§ Ficlatuzumab^§ Flotetuzumab^§ Gemtuzumab ozogamicin Glofitamab Imgatuzumab^§ Inotuzumab ozogamicin Labetuzumab^§ Lifastuzumab vedotin^§ Lintuzumab^§ Lorvotuzumab mertansine^§ Lumretuzumab^§ Matuzumab^§ Milatuzumab^§ Naxitamab Nimotuzumab^† Obinutuzumab Ocaratuzumab^§ Otlertuzumab^§ Onartuzumab^§ Oportuzumab monatox^† Parsatuzumab^§ Pertuzumab Pinatuzumab vedotin^§ Polatuzumab vedotin Rosmantuzumab Rovalpituzumab tesirine^† Sacituzumab govitecan Sibrotuzumab^§ Simtuzumab^§ Sofituzumab vedotin^§ Tacatuzumab tetraxetan^§ Tigatuzumab^§ Trastuzumab^# (+deruxtecan / +emtansine) Tucotuzumab celmoleukin^§ Vandortuzumab vedotin^§ Vanucizumab^§ Veltuzumab^§ Vorsetuzumab mafodotin^§
Rat/mouse hybrid	Catumaxomab Ertumaxomab^§
Chimeric + humanized	Depatuxizumab mafodotin^† Duvortuxizumab Ontuxizumab^§