AbbVie Inc. — Skyrizi EMA EPAR public assessment report (EMEA/H/C/004759, 2019)
AbbVie Inc. · 2019 · EMA EPAR public assessment report · company profile →
Report summary
The EMA's CHMP issued a positive opinion for AbbVie's Skyrizi (risankizumab) for moderate to severe plaque psoriasis in adults, leading to marketing authorization in February 2019. Skyrizi, an IL-23 inhibitor, demonstrated superior efficacy over placebo, ustekinumab, and adalimumab in Phase 3 trials, achieving significant improvements in PASI 90/100 and sPGA 0/1 scores. Pharmacokinetic studies showed typical monoclonal antibody characteristics with an 89% bioavailability and 28-day half-life. Non-clinical studies indicated no adverse effects on fertility or development. The safety profile was generally favorable, with most adverse events being mild to moderate. While some concerns regarding infections, malignancies, and MACE were noted, overall rates were comparable or more favorable than comparators. The convenient 12-week dosing regimen is expected to enhance patient compliance.
Key findings — cited to the page
| Elevations in glucose (CTC grade ≥ 3) (%) | 4.2 % | · p.160 |
| Triglyceride elevations (CTC grade ≥ 3) (%) | 4.7 % | · p.160 |
| CTC grade ≥ 3 clinical chemistry abnormalities (triglyceride elevations) (%) | 5.9 % | · p.148 |
| CTC Grade ≥ 3 clinical chemistry abnormalities (triglyceride elevations) (%) | 4.7 % | · p.148 |
| Percentage of grade 4 events (%) | 0.6 % | · p.148 |
| CTC grade ≥ 3 clinical chemistry abnormalities (glucose elevations) (%) | 4.7 % | · p.148 |
| CTC toxicity grade 3 for platelets | 1 case | · p.148 |
| CTC toxicity grade 3 for decreased Hb | 1 case | · p.148 |
| CTC toxicity grade 3 for lymphocytes | 6 cases | · p.148 |
| CTC Grade ≥ 3 clinical chemistry abnormalities (glucose elevations) (%) | 4.2 % | · p.148 |
| Percentage of grade 3 events (%) | 0.9 % | · p.148 |
| CTC toxicity grade 3 for leucocytes | 4 cases | · p.148 |
Source: AbbVie Inc. ↗ · 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 →