The European Commission has approved AbbVie's (NYSE: ABBV) Rinvoq (upadacitinib) for the treatment of active polyarticular juvenile idiopathic arthritis (pJIA) in patients two years of age and older who have not responded adequately to, or are intolerant to, one or more disease-modifying anti-rheumatic drugs (DMARDs).

The approval covers both a 15 mg tablet and a new weight-based 1 mg/mL oral solution formulation. Rinvoq may be used as monotherapy or in combination with methotrexate. The drug now holds 11 approved indications in the European Union.

The decision was supported by data from the SELECT-YOUTH study, a single-arm, open-label, global Phase 1 trial evaluating pharmacokinetics, efficacy, safety, and tolerability of upadacitinib in patients aged 2 to under 18 years, along with data from adult patients with rheumatoid arthritis.

In the study of 122 patients, 66.4% achieved a 70% improvement in disease activity at week 12, rising to 79.5% at week 48. Remission rates, measured by JADAS27-CRP score, were 23.0% at week 12 and 43.4% at week 48. Functional ability and pain scores also improved over the study period.

No new safety risks were identified in the pediatric study population. The rate of treatment-emergent adverse events was 499.6 events per 100 patient-years, while serious adverse events occurred at a rate of 10.2 per 100 patient-years. No major cardiovascular events, malignancies, or deaths were reported during the study period. No negative impact on growth or development was observed.

Juvenile idiopathic arthritis is estimated to affect approximately 126,000 children in Europe, according to the press release. The polyarticular subtype involves inflammation in five or more joints persisting for at least six weeks.