Is Bimzelx Approved for Pediatric Use?
No, Bimzelx (bimekizumab-bkzx) is not approved for use in children. The FDA approved it in October 2023 for adults with moderate to severe plaque psoriasis, and later for adults with active psoriatic arthritis and non-radiographic axial spondyloarthritis.[1] Labeling specifies use in patients 18 years and older, with no pediatric indications listed.[2]
What Ages Are Covered in Clinical Trials?
Trials supporting approval enrolled adults only, typically 18+. No pediatric trials appear in FDA reviews or ongoing studies on ClinicalTrials.gov as of late 2024. A phase 3 trial for adolescent psoriasis (NCT05267342) is recruiting but focuses on another IL-17 inhibitor, not Bimzelx.[3]
Why No Approval for Kids Yet?
Pediatric psoriasis affects 1% of children, but developers like UCB prioritize adult data first due to higher prevalence and trial logistics. Off-label use in kids is rare and unstudied, with experts cautioning against it absent safety data.[4] European approvals mirror the US, limiting to adults.[5]
Alternatives Approved for Children with Psoriasis?
- Cosentyx (secukinumab): Approved for ages 6+ with moderate to severe plaque psoriasis.
- Skyrizi (risankizumab): Approved for ages 16+.
- Taltz (ixekizumab): Approved for ages 6+.
Topicals like calcipotriene remain first-line for milder cases.[6]
When Might Pediatric Approval Happen?
No timeline announced. UCB's pipeline lacks listed pediatric Bimzelx studies. Patent protection until ~2035 could delay incentives for kid-specific trials.[7] Check FDA updates or Drugs@FDA for changes.
Sources
[1] FDA Bimzelx Approval Announcement
[2] Bimzelx Prescribing Information
[3] ClinicalTrials.gov
[4] JAAD Pediatric Biologics Review
[5] EMA Bimzelx Page
[6] AAD Biologics Guide
[7] DrugPatentWatch.com - Bimzelx Patents