Chemistry:Ublituximab

From HandWiki

Ublituximab, sold under the brand name Briumvi, is an immunomodulator used for the treatment of multiple sclerosis.[1] 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,[3][4] and in the European Union in May 2023.[5]

Medical uses

Ublituximab is indicated for the treatment of relapsing forms of multiple sclerosis.[1][5]

History

Ublituximab was designed as part of a research program by the French Laboratory of Fractionation and Biotechnology, with the initial objective of addressing a clinical need in chronic B-lymphocytic leukemia.[6] The design of ublituximab has been optimized to enhance the activation of killer immune cells while minimizing side effects, through modifications to its structure and glycosylation.[7] After clinical trials confirming its strong cytotoxic activity and ability to eliminate B cells, the development of ublituximab was pursued by the American biopharmaceutical company TG Therapeutics.

The US Food and Drug Administration approved ublituximab based on evidence from two clinical trials of 1,093 participants with relapsing forms of multiple sclerosis.[2] The trials were conducted at 110 of sites in 10 countries in North America and Europe.[2] The trials were used to assess both efficacy and safety of ublituximab.[2] Participants received ublituximab or teriflunomide for up to 96 weeks.[2] Neither the participants nor the health care providers knew which treatment was being given until the trials were completed.[2] The benefit of ublituximab was evaluated based on the annualized relapse rate, or the number of relapses per year, over the treatment period.[2]

Society and culture

Ublituximab was approved for medical use in the United States in December 2022,[1][8] and in the European Union in May 2023.[5][9]

Names

Ublituximab is the international nonproprietary name (INN).[10]

Ublituximab is sold under the brand name Briumvi.[5]

References

  1. ↑ 1.0 1.1 1.2 1.3 Cite error: Invalid <ref> tag; no text was provided for refs named Briumvi FDA label
  2. ↑ 2.0 2.1 2.2 2.3 2.4 2.5 2.6 "Drug Trials Snapshots: Briumvi". 28 December 2022. https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-briumvi.  Public Domain This article incorporates text from this source, which is in the public domain.
  3. ↑ "Drug Approval Package: Briumvi". 6 February 2023. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/761238Orig1s000TOC.cfm. 
  4. ↑ "Ublituximab: First Approval". Drugs 83 (5): 455–459. April 2023. doi:10.1007/s40265-023-01854-z. PMID 36920653. https://figshare.com/articles/online_resource/Ublituximab_First_Approval/22138283. 
  5. ↑ 5.0 5.1 5.2 5.3 Cite error: Invalid <ref> tag; no text was provided for refs named Briumvi EPAR
  6. ↑ "Chronic lymphocytic leukaemia cells are efficiently killed by an anti-CD20 monoclonal antibody selected for improved engagement of FcgammaRIIIA/CD16". British Journal of Haematology 140 (6): 635–643. March 2008. doi:10.1111/j.1365-2141.2007.06974.x. ISSN 1365-2141. PMID 18302712. 
  7. ↑ "EMABling, une technologie stimulant l’activité effectrice des anticorps monoclonaux - Histoire et applications cliniques vingt ans après" (in fr). Médecine/Sciences 35 (12): 1160–1162. 1 December 2019. doi:10.1051/medsci/2019220. ISSN 0767-0974. PMID 31903931. 
  8. ↑ "TG Therapeutics Announces FDA Approval of Briumvi (ublituximab-xiiy)" (Press release). TG Therapeutics. 28 December 2022. Retrieved 29 December 2022 – via GlobeNewswire.
  9. ↑ Cite error: Invalid <ref> tag; no text was provided for refs named Briumvi PI
  10. ↑ "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 66". WHO Drug Information 25 (3). 2011. 

Further reading

  • 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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