ABBVIE INC — Skyrizi FDA Review (NDA/BLA 761105, 2024)
AbbVie Inc. · 2024 · FDA Review (Drugs@FDA) · company profile →
Report summary
The FDA approved Skyrizi (risankizumab-rzaa) for active psoriatic arthritis (PsA) in adults in January 2022, following a comprehensive review of BLA 761105/S-014. This IL-23 inhibitor, previously approved for plaque psoriasis, demonstrated significant efficacy in two Phase 3 trials (M16-011, M15-998), showing superior ACR20 response rates, improved HAQ-DI, and PASI90 compared to placebo. The recommended dosing is 150 mg subcutaneously at Week 0, Week 4, and every 12 weeks thereafter. Safety data, consistent with its use in psoriasis, highlighted increased risks of infections, hypersensitivity reactions, and hepatic events (liver enzyme elevations). While immunogenicity was low, the FDA requested further data on hepatic and hypersensitivity events and proposed a post-marketing requirement for pediatric PsA pharmacokinetic and safety information. The review also covered pharmacokinetics, immunogenicity, and labeling consistency, ensuring appropriate warnings and precautions.
Key findings — cited to the page
| Leukocytes Grade 3 (%) | 0.3 % | · p.180 |
| Neutrophils Grade 3 (%) | 0.4 % | · p.181 |
| Hemoglobin Grade 3 (%) | < 0.1 % | · p.180 |
| Platelet Grade 3 or 4 (%) | 0 % | · p.180 |
| Neutrophils Grade 3 (%) | 0.3 % | · p.180 |
| Neutrophils Grade 3 (%) | 0.4 % | · p.180 |
| Hemoglobin Grade 3 or 4 (%) | 0.6 % | · p.180 |
| Hemoglobin Grade 3 or 4 (%) | 0 % | · p.180 |
| Hemoglobin Grade 4 (%) | < 0.1 % | · p.180 |
| Platelet Grade 3 (%) | 0.1 % | · p.180 |
| Leukocytes Grade 3 or 4 (%) | 0 % | · p.180 |
| Neutrophils Grade 3 (%) | 0.2 % | · p.181 |
Source: AbbVie Inc. ↗ · 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 →