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]
| 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 |
|
| 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 |
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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.[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
editUblituximab 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
editResearchers 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
editNames
editUblituximab is the international nonproprietary name (INN).[8]
References
edit- ^ 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.
Further reading
edit- 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. S2CID 251808946.
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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