AbbVie Inc. — Skyrizi FDA Review (BLA761105, ORIG 1, 2019)
AbbVie Inc. · 2019 · FDA Review (openFDA) · company profile →
Report summary
The FDA recommended approval for AbbVie Inc.'s Biologics License Application (BLA) 761105 for Skyrizi (risankizumab), an IL-23 antagonist, for treating moderate to severe plaque psoriasis in adults. Extensive Phase 2 and 3 trials demonstrated risankizumab's superior efficacy over placebo and active comparators (ustekinumab, adalimumab) in achieving significant improvements in PASI 90 and sPGA 0/1 scores, with durable responses up to Week 52. The safety profile indicated no increased risk of mortality, malignancy, SIB, or MACE, though a higher incidence of infections compared to placebo was noted. Immunogenicity was assessed, and the proposed 150 mg dosing regimen was deemed appropriate. Preclinical and clinical pharmacology, including pharmacokinetics and toxicology, supported the drug's profile. The Psoriasis Symptom Scale (PSS) was validated for assessing symptoms. Post-marketing studies are required for long-term safety monitoring.
Key findings — cited to the page
| sPGA score of 0 or 1 with at least 2-grade improvement from baseline | statistically superior | Trials 1311.28 and 1311.3 · p.145 |
| Discontinuation due to hepatic events | 0.2 % | · p.143 |
| Application Type | BLA | Skyrizi (Risankizumab) · p.2 |
| SAEs incidence | 2.4 % | · p.142 |
| Non-NMSC malignancies incidence | 0.62 E/100 PY | · p.142 |
| Opportunistic infections rate | 0.3 E/100 PY | · p.143 |
| Exposure-adjusted rate of adverse events over entire psoriasis program | 236.0 E/100 PY | · p.116 |
| Percentage of subjects experiencing adverse events over entire psoriasis program | 66.2 % | · p.116 |
| PASI 90 response rate (placebo) | 5% % | Skyrizi (risankizumab) · p.15 |
| Urticaria in risankizumab group | 0.5 % | · p.128 |
| Non-NMSC malignancies incidence | 0.5 E/100 PY | · p.142 |
| SAEs incidence | 4 % | · p.142 |
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 →