UCB SA — Bimzelx FDA Review (BLA761151, ORIG 1, 2023)
UCB SA · 2023 · FDA Review (openFDA) · company profile →
Report summary
The FDA review of UCB SA's BLA 761151 for BIMZELX (bimekizumab-bkzx) injection for moderate to severe plaque psoriasis recommends approval following resubmission. Initial approval was withheld due to GMP deficiencies, which have since been resolved. Efficacy was demonstrated in pivotal trials (PS0009, PS0013), showing superiority over placebo in achieving IGA 0/1 and PASI90 responses. The proposed dosing regimen is 320 mg every 4 weeks for 16 weeks, then every 8 weeks. Safety data from multiple trials revealed a new signal for suicidal ideation and behavior (SI/B), necessitating a prominent boxed warning. Other safety concerns include infections, inflammatory bowel disease, hepatotoxicity, and cardiovascular events. Despite these, the overall benefit-risk profile is deemed favorable with appropriate labeling. Postmarketing requirements include long-term safety, pregnancy, lactation, and pediatric studies.
Key findings — cited to the page
| IGA 0 or 1 with ≥2 grade improvement response rate (%) | 31 % | · p.190 |
| IGA 0 or 1 with ≥2 grade improvement response rate (%) | 14 % | · p.190 |
| Grade 3 neutropenia incidence (placebo) | 0.6 % | BIMZELX · p.332 |
| Fatalities adjudicated MACE | 8 | · p.97 |
| IGA 0/1 response rate | 53% | Trial PS0009 · p.262 |
| Proportion of psoriasis patients with moderate to severe disease | 20 % | U.S. · p.15 |
| TEAEs: Cardiac disorders (BKZ Q4W) | 1.7 % | PS0015 OLE · p.117 |
| Ctrough for bimekizumab 320 mg Q4W/Q8W | 16.89 µg/mL | PS0008 · p.212 |
| Relative risk of passive suicidal ideation | 3.0 | BIMZELX · p.14 |
| TEAEs leading to discontinuation: Eye disorders (BKZ Q4W) | 0.0 % | PS0014 · p.115 |
| Prevalence of psoriasis in the U.S. | 4.6 % | U.S. · p.15 |
| Subjects with passive suicidal ideation (placebo-treated) | 0.6 % | BIMZELX · p.14 |
Source: UCB SA ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Immunology library →