Abbott has submitted a supplemental Biologics License Application (sBLA) with the US Food and Drug Administration (FDA) and a type II variation to the European Medicines Agency (EMEA) seeking approval to market Humira (adalimumab) as a treatment for juvenile rheumatoid arthritis (JRA) in the US and juvenile idiopathic arthritis (JIA) in the European Union (EU). This filing marks the first paediatric indication sought for Humira.

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. Typical symptoms include persistent joint pain and stiffness that are usually worse in the morning or after a nap. The pain may limit movement of the affected joint, although many children will not complain of the pain. Walking with a limp is an early sign of JRA due to an affected knee. Depending on the severity of disease, JRA may affect bone development or cause growth abnormalities, such as one leg or arm growing longer than the other. The goal of treatment for JRA is to control inflammation, relieve pain, and preserve mobility and joint function, and ultimately prevent disease progression.

"If left untreated, JRA may slow a child's growth and cause disability into adulthood," said Daniel J. Lovell, MD, MPH, associate director, special treatment Centre for Juvenile Arthritis, Cincinnati Children's Hospital Medical Centre, Cincinnati. "Humira may offer hope to children suffering with this unpredictable disease."

Humira is approved to treat adult patients with moderately to severely active rheumatoid arthritis. More than 180,000 patients worldwide are currently being treated with Humira. Humira is currently being studied in paediatric Crohn's disease, and Abbott plans to initiate trials for paediatric and adolescent psoriasis later this year.

"We are pleased by the submission of our first paediatric indication for Humira," said Eugene Sun, MD, vice president, Global Pharmaceutical Clinical Development at Abbott. "Humira has already benefited thousands of adults suffering with RA, and this trial shows promise for children and families who are impacted by JRA."