AbbVie receives EU approval for RINVOQ in juvenile idiopathic arthritis

• AbbVie (NYSE:ABBV) received European Commission approval for RINVOQ (upadacitinib) to treat active polyarticular juvenile idiopathic arthritis.
• The approval expands RINVOQ’s use to children aged two years and older with inadequate response or intolerance to at least one DMARD.
• Phase 1 SELECT-YOUTH data showed improvements in disease activity, remission rates, physical function and pain outcomes.

AbbVie (NYSE:ABBV) announced that the European Commission has approved RINVOQ® (upadacitinib) 15 mg tablets and 1 mg/mL oral solution for the treatment of active polyarticular juvenile idiopathic arthritis (pJIA).

The approval applies to patients aged two years and older who have experienced an inadequate response or intolerance to at least one disease-modifying antirheumatic drug (DMARD).

RINVOQ may be used as a monotherapy or in combination with methotrexate.

The expanded indication is supported by data from the open-label Phase 1 SELECT-YOUTH study, along with established efficacy and safety data from adult rheumatoid arthritis studies.

In SELECT-YOUTH, which enrolled 122 patients, RINVOQ demonstrated improvements across multiple measures of disease activity.

The American College of Rheumatology pediatric 70 response rate reached 66.4% at Week 12 and increased to 79.5% at Week 48.

Disease remission, measured by Juvenile Arthritis Disease Activity Score using C-reactive protein (JADAS27-CRP ≤1), was achieved by 23.0% of patients at Week 12 and 43.4% at Week 48.

Patients also experienced improvements in physical function and pain.

Mean Childhood Health Assessment Questionnaire (C-HAQ) scores improved by −0.46 at Week 12 and −0.64 at Week 48, while pain scores improved by −26.2 and −30.8 points at the respective time points.

AbbVie reported that no new safety risks were identified in the study. No major cardiovascular events, thrombotic events, malignancies, deaths or impacts on growth and development were observed.

With this approval, RINVOQ is now authorized in the European Union for 11 different indications.