Chemistry:Bimekizumab

From HandWiki

Bimekizumab, sold under the brand name Bimzelx (/bɪmˈzɛlɪks/ bim-ZEL-iks), is a humanized anti-IL17A, anti-IL-17F, and anti-IL17AF monoclonal antibody[1][2] that is used to treat plaque psoriasis, psoriatic arthritis, axial spondyloarthritis, ankylosing spondylitis, and hidradenitis suppurativa.[1]

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).[1] Injection site reactions were also common, reported in 3% of subjects.[3]

Bimekizumab was approved for medical use in the European Union in August 2021,[1][4][5] and in the United States in October 2023.[6][7]

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.[8]

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.[1]

Society and culture

Names

Bimekizumab is the international nonproprietary name (INN).[9]

Research

Phase III trials have demonstrated that bimekizumab is superior to not only adalimumab[10] but also secukinumab[11] and ustekinumab[12] 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.[13][14][15]

References

  1. ↑ 1.0 1.1 1.2 1.3 1.4 Cite error: Invalid <ref> tag; no text was provided for refs named Bimzelx EPAR
  2. ↑ "Systematic review of immunomodulatory therapies for hidradenitis suppurativa". Biologics: Targets and Therapy 13: 53–78. 13 May 2019. doi:10.2147/BTT.S199862. PMID 31190730. 
  3. ↑ FDA Professional Drug Information
  4. ↑ "Bimzelx Product information". https://ec.europa.eu/health/documents/community-register/html/h1575.htm. 
  5. ↑ "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.
  6. ↑ "FDA Approves Bimekizumab for Plaque Psoriasis in Adults". 18 October 2023. https://www.medscape.com/viewarticle/997490. 
  7. ↑ "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.
  8. ↑ 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" (in en). https://www.prnewswire.com/news-releases/ucb-receives-us-fda-approval-for-bimzelx-bimekizumab-bkzx-as-the-first-il-17a-and-il-17f-inhibitor-for-adults-with-moderate-to-severe-hidradenitis-suppurativa-302311330.html. 
  9. ↑ "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 72". WHO Drug Information 28 (3). 2014. 
  10. ↑ "Bimekizumab versus Adalimumab in Plaque Psoriasis". The New England Journal of Medicine 385 (2): 130–141. July 2021. doi:10.1056/NEJMoa2102388. PMID 33891379. 
  11. ↑ "Bimekizumab versus Secukinumab in Plaque Psoriasis". The New England Journal of Medicine 385 (2): 142–152. July 2021. doi:10.1056/NEJMoa2102383. PMID 33891380. 
  12. ↑ "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. February 2021. doi:10.1016/S0140-6736(21)00125-2. PMID 33549193. 
  13. ↑ "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. June 2024. doi:10.1016/S0140-6736(24)00101-6. PMID 38795716. 
  14. ↑ "A Study to Evaluate the Efficacy and Safety of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa (BE HEARD I)". https://clinicaltrials.gov/study/NCT04242446. 
  15. ↑ "A Study to Evaluate the Efficacy and Safety of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa (BE HEARD II)". https://clinicaltrials.gov/study/NCT04242498. 

Further reading

  • "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. August 2019. doi:10.1007/s40259-019-00361-6. PMID 31172372. 



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