AbbVie's Humira cleared in EU for polyarticular juvenile idiopathic arthritis

The European Commission has approved an extension of the European Union marketing authorization for US drugmaker AbbVie’s (NYSE: ABBV) blockbuster rheumatoid arthritis drug Humira (adalimumab) for the treatment of polyarticular juvenile idiopathic arthritis (JIA) in children and adolescents aged two to 17 years who have had an inadequate response to one or more disease modifying anti-rheumatic drugs (DMARDs), expanded from its originally approved label for children aged four to 17 years that was granted by the EC in 2008.

“JIA commonly presents in early childhood between the ages of two to four years, and to date, approved therapeutic options have been limited,” said Daniel Kingsbury, medical director, Pediatric Rheumatology at Randall Children's Hospital in Portland, Oregon quoted by AbbVie.

The EC approval for the label extension was supported by a study evaluating the safety and efficacy of Humira in 32 children with moderately to severely active polyarticular JIA aged two to less than four years or aged four and above weighing less than 15 kilograms. This study data showed that Humira was efficacious in this younger patient population. At weeks 12 and 24, 93.5% and 90% of patients, respectively, achieved at least 30% improvement in the pediatric ACR criteria (PedACR30).