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 |
|
| Routes of administration | Intravenous |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| DrugBank | |
| ChemSpider |
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| 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][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]
- ^ a b c d "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 "Briumvi EPAR". European Medicines Agency. 13 July 2023. Archived from the original on 14 July 2023. Retrieved 13 July 2023.
- ^ a b "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.
- ^ "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.