EU Regulators Approve AbbVie’s Rinvoq for Pediatric Arthritis

The regulatory decision covers patients with polyarticular rheumatoid factor-positive or negative, as well as extended oligoarticular forms of the disease. Rinvoq, a JAK inhibitor developed by AbbVie, can now be administered as a monotherapy or in combination with methotrexate. Juvenile idiopathic arthritis remains the most prevalent rheumatic condition in childhood, affecting approximately 126,000 children across Europe.

Clinical support for the approval came from the Phase 1 SELECT-YOUTH study, which monitored participants aged 2 to 18. Data indicated that nearly 80 percent of patients achieved a 70 percent improvement in disease activity by week 48. Furthermore, participants experienced notable gains in functional ability and reduced pain levels. Researchers noted no new safety signals during the study period, with no reported instances of major cardiovascular events, malignancies, or deaths. AbbVie expects this new indication to broaden its immunology portfolio, providing a systemic treatment option for one of the most vulnerable patient populations.