AbbVie Inc. — Rinvoq FDA Review (NDA218347, ORIG 1, 2024)
AbbVie Inc. · 2024 · FDA Review (openFDA) · company profile →
Report summary
The FDA has reviewed AbbVie's Rinvoq (upadacitinib) for pediatric polyarticular juvenile idiopathic arthritis (pJIA) and pediatric psoriatic arthritis (PsA) in patients aged 2 years and older, including a new oral immediate-release solution. The review recommends approval for both indications, based on efficacy extrapolation from adult data and supportive safety findings from Study M15-340. Pharmacokinetic and efficacy bridging strategies confirmed comparable exposures and efficacy to adult populations. While no new safety signals were identified, long-term safety data are limited, necessitating post-marketing studies for malignancies, infections, thromboses, and growth effects. The new oral solution formulation was also approved from a product quality and nonclinical safety perspective.
Key findings — cited to the page
| Subjects with Grade 3 ALT elevations | 3.6 % | Study M15-340 · p.120 |
| Number of subjects for Grade 2 clinical AE discontinuation | 2 subjects | M15-340 · p.86 |
| Subjects with Grade 2 neutrophil decreases | 12 | Study M15-340 · p.119 |
| Subjects with decreased platelets (Grade 2) | 6.0 % | Study M15-340 · p.120 |
| Subjects with Grade 3 CPK abnormalities | 3.6 % | Study M15-340 · p.121 |
| PQRI Thresholds for sensitizer and irritants, non-genotoxic/non-carcinogenic | 5 µg/day | · p.179 |
| Subjects with Grade 3 TEAEs | 13.3 % | Study M15-340 · p.118 |
| Subjects with Grade 3 decreased neutrophils | 1 | Study M15-340 · p.119 |
| Subjects with Grade 1 neutrophil decreases | 5 | Study M15-340 · p.119 |
| Subjects with leukocyte changes from baseline (Grade 1) | 33.8 % | Study M15-340 · p.119 |
| Subjects with Grade 4 CPK abnormalities | 2.4 % | Study M15-340 · p.121 |
| Number of subjects for Grade 2 hypersensitivity discontinuation | 2 subjects | M15-340 · p.86 |
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 →