Bimekizumab

Bimekizumab
Monoclonal antibody
TypeWhole antibody
SourceHumanized
TargetIL17A, IL17F, IL17AF
Clinical data
Trade namesBimzelx
Other namesUCB4940, bimekizumab-bkzx
License data
Pregnancy
category
Routes of
administration		Subcutaneous
ATC code
Legal status
Legal status
Identifiers
CAS Number
DrugBank
UNII
KEGG
Chemical and physical data
FormulaC6552H10132N1750O2029S42
Molar mass147229.87 g·mol−1

Bimekizumab, sold under the brand name Bimzelx, is a humanized anti-IL17A, anti-IL-17F, and anti-IL17AF monoclonal antibody[6][7] that is used to treat plaque psoriasis, psoriatic arthritis, axial spondyloarthritis, ankylosing spondylitis and hidradenitis suppurativa.[6]

The most common side effects include upper respiratory tract infections (nose and throat infection) and oral candidiasis (thrush, a fungal infection in the mouth or throat).[6] Injection site reactions were also common, reported in 3% of subjects.[8]

Bimekizumab was approved for medical use in the European Union in August 2021,[6][9][10] and in the United States in October 2023.[11][12]

In November 2024, bimekizumab was approved by the US Food and Drug Administration for the treatment of active moderate-to-severe hidradenitis suppurativa in adults.[13]

Medical uses

In the EU, bimekizumab is indicated for the treatment of moderate to severe plaque psoriasis, active psoriatic arthritis, non-radiographic axial spondyloarthritis, and active ankylosing spondylitis.[6]

Society and culture

Names

Bimekizumab is the international nonproprietary name (INN).[14]

Research

Phase III trials have demonstrated that bimekizumab is superior to not only adalimumab[15] but also secukinumab[16] and ustekinumab[17] for the treatment of plaque psoriasis.

The approval for the treatment of active moderate-to-severe hidradenitis suppurativa (HS) in adults was supported by data from two Phase 3 studies, BE HEARD I and BE HEARD II, which evaluated the efficacy and safety of bimekizumab in the treatment of adults with moderate-to-severe HS.[18][19][20]

References

  1. ^ a b "Bimzelx APMDS". Therapeutic Goods Administration (TGA). 7 April 2022. Archived from the original on 24 April 2022. Retrieved 24 April 2022.
  2. ^ "Updates to the Prescribing Medicines in Pregnancy database". Therapeutic Goods Administration (TGA). 21 December 2022. Archived from the original on 3 April 2022. Retrieved 2 January 2023.
  3. ^ "Bimzelx Product information". Health Canada. 25 April 2012. Archived from the original on 29 June 2022. Retrieved 29 June 2022.
  4. ^ "Regulatory Decision Summary for Bimzelx". Drug and Health Products Portal. 23 February 2024. Retrieved 1 April 2024.
  5. ^ "Bimzelx- bimekizumab injection, solution". DailyMed. 20 October 2023. Retrieved 10 November 2023.
  6. ^ a b c d e f "Bimzelx EPAR". European Medicines Agency (EMA). 23 June 2021. Archived from the original on 25 August 2021. Retrieved 24 August 2021. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  7. ^ Lim SY, Oon HH (13 May 2019). "Systematic review of immunomodulatory therapies for hidradenitis suppurativa". Biologics: Targets and Therapy. 13: 53–78. doi:10.2147/BTT.S199862. PMC 6526329. PMID 31190730.
  8. ^ FDA Professional Drug Information
  9. ^ "Bimzelx Product information". Union Register of medicinal products. Archived from the original on 4 March 2023. Retrieved 3 March 2023.
  10. ^ "UCB Announces European Commission Approval of Bimzelx (bimekizumab) for the Treatment of Adults with Moderate to Severe Plaque Psoriasis". UCB (Press release). 24 August 2021. Archived from the original on 25 August 2021. Retrieved 24 August 2021.
  11. ^ Frellick M (18 October 2023). "FDA Approves Bimekizumab for Plaque Psoriasis in Adults". Medscape. Archived from the original on 28 October 2023. Retrieved 28 October 2023.
  12. ^ "Bimzelx Approved by the U.S. FDA for the Treatment of Adults with Moderate to Severe Plaque Psoriasis". UCB (Press release). 18 October 2023. Archived from the original on 28 October 2023. Retrieved 28 October 2023.
  13. ^ UCB. "UCB Receives U.S. FDA Approval for BIMZELX® (bimekizumab-bkzx) as the First IL-17A and IL-17F Inhibitor for Adults with Moderate-to-Severe Hidradenitis Suppurativa". www.prnewswire.com. Retrieved 20 November 2024.
  14. ^ World Health Organization (2014). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 72". WHO Drug Information. 28 (3). hdl:10665/331112.
  15. ^ Warren RB, Blauvelt A, Bagel J, Papp KA, Yamauchi P, Armstrong A, et al. (July 2021). "Bimekizumab versus Adalimumab in Plaque Psoriasis". The New England Journal of Medicine. 385 (2): 130–141. doi:10.1056/NEJMoa2102388. PMID 33891379. S2CID 233372177.
  16. ^ Reich K, Warren RB, Lebwohl M, Gooderham M, Strober B, Langley RG, et al. (July 2021). "Bimekizumab versus Secukinumab in Plaque Psoriasis". The New England Journal of Medicine. 385 (2): 142–152. doi:10.1056/NEJMoa2102383. PMID 33891380. S2CID 233370455.
  17. ^ Reich K, Papp KA, Blauvelt A, Langley RG, Armstrong A, Warren RB, et al. (February 2021). "Bimekizumab versus ustekinumab for the treatment of moderate to severe plaque psoriasis (BE VIVID): efficacy and safety from a 52-week, multicentre, double-blind, active comparator and placebo controlled phase 3 trial". Lancet. 397 (10273): 487–498. doi:10.1016/S0140-6736(21)00125-2. PMID 33549193. S2CID 231809826.
  18. ^ Kimball AB, Jemec GB, Sayed CJ, Kirby JS, Prens E, Ingram JR, et al. (June 2024). "Efficacy and safety of bimekizumab in patients with moderate-to-severe hidradenitis suppurativa (BE HEARD I and BE HEARD II): two 48-week, randomised, double-blind, placebo-controlled, multicentre phase 3 trials". Lancet. 403 (10443): 2504–2519. doi:10.1016/S0140-6736(24)00101-6. PMID 38795716.
  19. ^ "A Study to Evaluate the Efficacy and Safety of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa (BE HEARD I)". clinicaltrials.gov. Retrieved 20 November 2024.
  20. ^ "A Study to Evaluate the Efficacy and Safety of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa (BE HEARD II)". clinicaltrials.gov. Retrieved 20 November 2024.

Further reading

  • Reis J, Vender R, Torres T (August 2019). "Bimekizumab: The First Dual Inhibitor of Interleukin (IL)-17A and IL-17F for the Treatment of Psoriatic Disease and Ankylosing Spondylitis". BioDrugs. 33 (4): 391–399. doi:10.1007/s40259-019-00361-6. PMID 31172372. S2CID 174812750.