AbbVie Announces European Commission Approval of RINVOQ® (upadacitinib) for the Treatment of Children with Active Polyarticular Juvenile Idiopathic Arthritis
The European Commission approved AbbVie's RINVOQ (upadacitinib; 15 mg tablet and weight-based 1 mg/mL oral solution) for active polyarticular juvenile idiopathic arthritis in patients two years of age and older with inadequate response to or intolerance of one or more DMARDs, usable as monotherapy or with methotrexate. Approval was based on the single-arm, open-label Phase 1 SELECT-YOUTH study plus adult rheumatoid arthritis data: ACR pediatric 70 response reached 66.4% at week 12 and 79.5% at week 48, remission (JADAS27-CRP ≤1) reached 43.4% at week 48, and no new safety risks were identified.
Key figures
- Drug Name
- RINVOQ (upadacitinib)
- Phase Of Trial
- Phase 1 (SELECT-YOUTH)
- Study population n
- 122
- Eu indications count
- 11
- Min patient age years
- 2
- Acrp70 response week12
- 66.4%
- Acrp70 response week48
- 79.5%
- Jia children in europe
- 126000
- Remission jadas27 week12
- 23.0%
- Remission jadas27 week48
- 43.4%
- Sae rate per 100 patient years
- 10.2
- Teae rate per 100 patient years
- 499.6
- Discontinuation rate per 100 patient years
- 2.7
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