UCB S A — Bimzelx EMA EPAR public assessment report (EMEA/H/C/005316, 2021)
UCB S A · 2021 · EMA EPAR public assessment report · company profile →
Report summary
The EMA granted marketing authorization for Bimzelx (bimekizumab) in June 2021 for moderate to severe plaque psoriasis. This IL-17A and IL-17F inhibitor demonstrated superior efficacy over placebo, adalimumab, and ustekinumab in Phase 3 trials (BE SURE, BE VIVID, PS0013), achieving rapid and sustained PASI90/100 and IGA 0/1 responses. The recommended dosing is 320mg Q4W induction, followed by 320mg Q8W maintenance. Non-clinical studies confirmed bimekizumab's potent inhibitory activity and acceptable safety profile, despite some infection risks in monkeys. Clinical trials showed consistent efficacy across various psoriasis manifestations and patient subgroups. Safety data revealed common adverse events, primarily infections (especially oral candidiasis), which were generally mild. Serious adverse events were low. Important identified risks include serious infections, hypersensitivity, IBD, MACE, and malignancy, necessitating ongoing monitoring. The CHMP concluded a positive benefit-risk balance for Bimzelx.
Key findings — cited to the page
| Grade 3 decreases in neutrophils | 14 (0.8) % | · p.211 |
| Grade 4 decreases in neutrophils | 2 (0.1) % | · p.211 |
| CTCAE Grade 3 neutrophil decrease (Pool S2) | 0.8 % | Pool S2 · p.182 |
| CTCAE Grade 3 neutrophil shift (BKZ 320mg Q4W) | 0.3 % | · p.182 |
| CTCAE Grade 1 neutrophil decrease (Pool S2) | 5.7 % | Pool S2 · p.182 |
| CTCAE Grade 2 neutrophil decrease (Pool S2) | 4.7 % | Pool S2 · p.182 |
| Neutrophil reduction Grade 2 (BKZ 320mg Q4W) | 1.3 % | · p.182 |
| Neutrophil reduction Grade 1 (BKZ 320mg Q4W) | 5.2 % | · p.182 |
| CTCAE Grade 1 neutrophil shift (BKZ 320mg Q4W) | 5.1 % | · p.182 |
| CTCAE Grade 2 neutrophil shift (BKZ 320mg Q4W) | 1.0 % | · p.182 |
| CTCAE Grade 2 neutrophil reduction (placebo group) | 1.2 % | · p.182 |
| Neutrophil reduction Grade 4 (BKZ 320mg Q4W) | 0.6 % | · p.182 |
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 →