AbbVie has received approval from the European Commission for their medication Rinvoq (upadacitinib) to treat children aged two years and older who have active polyarticular juvenile idiopathic arthritis (pJIA). This condition is a type of childhood arthritis that affects five or more joints for at least six weeks and can cause long-term joint damage if left untreated. Rinvoq is now approved for children who have not responded well to or cannot tolerate one or more standard arthritis medications called DMARDs. The approval covers both a 15 mg tablet and a new oral solution that adjusts the dose based on the child’s weight.
Roopal Thakkar, Chief Scientific Officer at AbbVie, explained, ‘The European Commission’s approval of Rinvoq for pJIA gives children and their families another treatment option that could help put the disease into remission, reduce pain, and improve physical function.’ This approval adds to AbbVie’s existing range of treatments for immune-related conditions, supporting patients across different age groups and conditions.
Juvenile idiopathic arthritis is the most common rheumatic disease in children, affecting around 126,000 children in Europe. Polyarticular JIA, in particular, can lead to serious joint damage if not properly managed.
The approval is backed by results from the SELECT-YOUTH study, a phase 1 clinical trial that tested Rinvoq in children aged two to under 18 years. The study evaluated how the medication is absorbed, its effectiveness, safety, and how well it is tolerated. The study also included data from adults with rheumatoid arthritis.
The results showed that Rinvoq starts working as early as 12 weeks, with improvements continuing up to 48 weeks. Children in the study experienced better ability to perform daily activities and reduced pain over this period. Importantly, the study did not identify any new safety concerns. No serious heart or blood clot events, cancers, or deaths were reported, and the medication did not negatively affect growth or development in the children.
Prof Dr Gerd Horneff, a pediatric specialist from Asklepios Clinic in Germany, commented, ‘The results from the SELECT-YOUTH study show that putting children with pJIA into remission is not just a possibility but a realistic goal. This can help protect them from permanent joint damage, which is especially important for our youngest and most vulnerable patients. The approval of Rinvoq provides a new oral treatment option for children suffering from this often-debilitating condition.’
With this approval, Rinvoq is now authorized in the European Union for 11 different immune-related, inflammatory conditions.