AbbVie Inc. — Rinvoq EMA EPAR variation assessment report (EMEA/H/C/004760, 2019)
AbbVie Inc. · 2019 · EMA EPAR variation assessment report · company profile →
Report summary
This report summarizes AbbVie's Type II variation application for Rinvoq (upadacitinib) to extend its indication to non-segmental vitiligo in adults and adolescents aged 12 and older. Supported by two replicate Phase 3 studies (M19-044 Study 1 and Study 2) and integrated long-term safety data, the application demonstrated significant efficacy. Upadacitinib 15 mg QD met co-primary endpoints (T-VASI 50 and F-VASI 75 at Week 48) and all ranked secondary endpoints, showing statistically significant improvements over placebo. Pharmacokinetic analyses confirmed comparable exposure across populations. The safety profile was consistent with other indications, with common adverse events like nasopharyngitis and upper respiratory tract infection, and a higher incidence of herpes zoster in the upadacitinib group. The report also addresses JAK inhibitor class warnings and patient information regarding potential risks. The CHMP adopted a positive opinion on June 25, 2026.
Key findings — cited to the page
| Grade 3 PCI laboratory abnormalities of increased AST or TBL values (upadacitinib group) | 1 subject each | · p.117 |
| Grade 3 PCI laboratory abnormalities of increased ALT, AST, and TBL values (all upadacitinib 15 mg cohort) | 1 subject each | · p.117 |
| Grade 3 laboratory value decreases in neutrophil count (upadacitinib group) | 4 (1.0%) | · p.116 |
| Grade 3 laboratory value decreases in lymphocyte count (placebo group) | 0 | · p.116 |
| Grade 3 laboratory increases in cholesterol (any upadacitinib 15 mg cohort) | 4 (0.9%) | · p.118 |
| Grade 3 laboratory increases in triglycerides (any upadacitinib 15 mg cohort) | 8 (1.8%) | · p.118 |
| Grade 3 laboratory value decrease in haemoglobin (placebo group) | 1 (0.5%) | · p.116 |
| Grade 3 laboratory value decrease in haemoglobin (upadacitinib group) | 1 (0.2%) | · p.116 |
| Grade 3 laboratory value decreases in neutrophil count (placebo group) | 1 (0.5%) | · p.116 |
| Grade 3 laboratory value decreases in lymphocyte count (upadacitinib group) | 3 (0.7%) | · p.116 |
| Number of replicate Phase 3 studies for NSV | 2 | M19-044 · p.12 |
| Application submission date | 28 January 2026 | Rinvoq · p.7 |
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 →