Ublituximab

Ublituximab
Monoclonal antibody
TypeWhole antibody
SourceChimeric (mouse/human)
TargetCD20
Names
Trade namesBriumvi
Other namesublituximab-xiiy
Clinical data
Main usesMultiple sclerosis[1]
Side effectsInfusion reaction, upper respiratory tract infection[1]
WHO AWaReUnlinkedWikibase error: ⧼unlinkedwikibase-error-statements-entity-not-set⧽
Routes of
use		Intravenous
Typical dose450 mg[1]
External links
AHFS/Drugs.comMonograph
Legal
License data
Legal status
Chemical and physical data
FormulaC6418H9866N1702O2006S48
Molar mass144504.31 g·mol−1

Ublituximab, sold under the brand name Briumvi, is a medication used to treat multiple sclerosis.[1] Specifically it is used for clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.[1] It is given by injection into a vein.[1]

Common side effects include infusion reactions and upper respiratory tract infections.[1] Other side effects may include infections and low immunoglobulins.[1] Use during pregnancy may harm the baby.[1] It is a monoclonal antibody directed against CD20.[1]

Ublituximab was approved for medical use in the United States in 2022.[1] In 2023 it received a positive opinion by regulators in Europe.[2] In the United States it costs about 64,000 USD per year as of 2023.[3]

Medical uses

Ublituximab is used to treat relapsing forms of multiple sclerosis.[1][4] It decreases relapses per year by about 50%.[2]

Dosage

The initial doses are generally 150 mg followed two weeks later by 450 mg.[1] Further doses of 450 mg are than given every 24 weeks.[1]

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).[5]

References

  1. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 "Briumvi- ublituximab injection, solution, concentrate". DailyMed. 19 January 2023. Archived from the original on 21 January 2023. Retrieved 21 January 2023.
  2. 1 2 "Briumvi: Pending EC decision". European Medicines Agency. 28 March 2023. Archived from the original on 8 April 2023. Retrieved 11 April 2023.
  3. ↑ "Ublituximab-Xiiy". Archived from the original on 11 April 2023. Retrieved 11 April 2023.
  4. 1 2 3 4 5 "FDA Roundup: December 30, 2022". U.S. Food and Drug Administration (FDA) (Press release). 30 December 2022. Archived from the original on 30 December 2022. Retrieved 30 December 2022. Public Domain This article incorporates text from this source, which is in the public domain.
  5. ↑ World Health Organization (2011). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 66". WHO Drug Information. 25 (3). hdl:10665/74683.
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