UCB S A — Bimzelx EMA EPAR variation assessment report (EMEA/H/C/005316, 2021)

UCB S A · 2021 · EMA EPAR variation assessment report · company profile →

Report summary

This report summarizes the assessment of pediatric studies for Bimzelx (bimekizumab) in adolescent plaque psoriasis. The Phase 2 study (PS0020) evaluated pharmacokinetics, safety, and efficacy of two bimekizumab doses over 20 weeks, with a 104-week open-label extension. Both doses showed similar PASI90 and IGA 0/1 response rates at Week 16, with Dose A demonstrating faster PASI75 response. Safety was consistent with adult data, with no new signals. While immunogenicity (ADAb and NAb positivity) was higher in adolescents, its clinical impact was deemed not meaningful. PS0020 data was considered inconclusive for long-term PK and immunogenicity. A global Phase 3 study (PS0021) for pediatric plaque psoriasis began in June 2024 and is expected to conclude by November 2030.

Key findings — cited to the page

Marketing authorisation date for Bimzelx in EU	20 August 2021	Bimzelx (bimekizumab) · EU · p.4
Study phase	Phase 2	PS0020 · p.4
Study completion date	12 March 2025	PS0020 · p.4
Age range for paediatric population waiver	0 to <6 years	Bimzelx (bimekizumab) · p.4
Age range for children in PIP	6 to 11 years	Bimzelx (bimekizumab) · p.4
Age range for adolescents in PIP	12 to <18 years	Bimzelx (bimekizumab) · p.4
Duration of Initial Treatment Period	20 weeks	PS0020 · p.7
Duration of Open-label Extension Period	104 weeks	PS0020 · p.7
Duration of Safety Follow-up Period	20 weeks	PS0020 · p.7
Study initiation date	06 April 2021	PS0020 · p.7
Dose A for participants >=65kg	320mg	PS0020 · p.7
EMA decision date for PIP	10 August 2022	Bimzelx (bimekizumab) · EU · p.4

Source: UCB S A ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Immunology library →