Abbott seeks additional Humira approval

Specifically, Abbott has applied to market Humira (adalimumab) as a treatment for juvenile rheumatoid arthritis (JRA) in the US and juvenile idiopathic arthritis (JIA) in the European Union. This filing marks the first pediatric indication sought for the drug.

Humira has already been approved to treat adults with moderate to severe rheumatoid arthritis.

JRA, commonly referred to as JIA in the EU, is the most common form of arthritis in children and normally begins before the age of 16. The goal of treatment for JRA is to control inflammation, relieve pain, and preserve mobility and joint function, and ultimately prevent disease progression.

The global filing is based on the results of a phase III, 48-week study that included 171 children (four to 17 years old) with polyarticular JRA, a form of arthritis affecting five or more joints, usually the same joints on both sides of the body. Additional data will be submitted from an ongoing open label extension study evaluating the long-term efficacy and safety of Humira.