US biopharmaceutical company AbbVie (NYSE: ABBV) said on Tuesday it has received European Commission approval for RINVOQ (upadacitinib) to treat active polyarticular juvenile idiopathic arthritis in patients aged two years and older who have responded inadequately to, or are intolerant of, one or more disease-modifying anti-rheumatic drugs.

The authorisation covers a 15 mg tablet and a new weight-based oral solution, which may be used alone or with methotrexate.

Approval was supported by the open-label Phase 1 SELECT-YOUTH study and data from adults with rheumatoid arthritis. SELECT-YOUTH evaluated pharmacokinetics, efficacy, safety and tolerability in patients aged 2 to under 18 years, with efficacy observed from week 12 and improving through week 48.

The safety profile in paediatric patients with polyarticular juvenile idiopathic arthritis was consistent with the known profile of RINVOQ across indications, with serious infections reported as the most common serious adverse reactions.

Polyarticular juvenile idiopathic arthritis is a subtype of juvenile idiopathic arthritis affecting five or more joints and can lead to persistent symptoms, flares and potential joint damage. It is estimated to affect about 126,000 children in Europe.

RINVOQ is a selective and reversible JAK inhibitor already authorised in the European Union for 11 immune-mediated inflammatory diseases, including rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, ulcerative colitis, Crohn's disease, atopic dermatitis, alopecia areata, vitiligo and giant cell arteritis.