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
UCB Pharma S.A. submitted a Type II variation for Bimzelx (bimekizumab) to extend its indication to active psoriatic arthritis (PsA) in adults. Non-clinical studies confirmed bimekizumab's IL-17A and IL-17F inhibition. Clinical pharmacokinetic and pharmacodynamic modeling, including Phase I, II, and III studies (BE OPTIMAL, BE COMPLETE), supported the 160mg Q4W dosing, with a higher initial dose for PsA patients with moderate to severe psoriasis. Efficacy data from Phase 3 trials (PA0010, PA0011) demonstrated bimekizumab's superiority over placebo in achieving ACR50, PASI90, and MDA responses, and inhibiting structural progression. Safety data, including pooled analyses, showed common adverse events like nasopharyngitis and upper respiratory tract infections, consistent with its known profile, with no clinically meaningful impact from covariates or immunogenicity on efficacy. The report concludes with an overview of the risk management plan.
Key findings — cited to the page
| PASI100 (NRI) | 66.7 % | PA0009 · p.168 |
| vdHmTSS mean change from Baseline | -0.14 | · p.166 |
| ACR50 responders (NRI) | 63.5 % | PA0009 · p.168 |
| ACR50 responders (NRI) | 60.2 % | PA0009 · p.168 |
| ACR70 responders (NRI) | 45.3 % | PA0009 · p.168 |
| ACR70 responders (NRI) | 44.8 % | PA0009 · p.168 |
| PASI75 responder rates | 88.3 % | PA0009 · p.168 |
| PASI90 responder rates | 80.0 % | PA0009 · p.168 |
| PASI100 responder rates | 70.8 % | PA0009 · p.168 |
| PASI75 (NRI) | 88.3 % | PA0009 · p.168 |
| PASI75 (NRI) | 76.7 % | PA0009 · p.168 |
| PASI100 (NRI) | 65.8 % | PA0009 · p.168 |
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 →