Abbott seeks EU approval for JIA treatment

Abbott has announced it has applied for marketing authorisation for Humira (adalimumab) as a treatment for juvenile idiopathic arthritis (JIA) with the European Medicines Agency.

The company has simultaneously submitted a supplemental biologics license application for the compound as a therapy for the condition in the US – where it is known as juvenile rheumatoid arthritis (JRA).

Humira is a fully human monoclonal antibody that functions by blocking tumour necrosis factor alpha and is approved in the EU and US as a treatment for ankylosing spondylitis, psoriatic arthritis and rheumatoid arthritis.

Daniel J Lovell, associate director at the special treatment centre for juvenile arthritis at Cincinnati Children’s Hospital Medical Centre, said: “If left untreated, JRA may slow a child’s growth and cause disability into adulthood.”

The company reports that the compound has already been of benefit to thousands of adult patients suffering from rheumatoid arthritis and added that recent trial results upon which the applications for marketing approval are based displayed “promise” for children affected by JIA.

Last month, Abbott announced it had opened a new manufacturing plant based in Puerto Rico for the long-term supply of Humira and other compounds, with this facility becoming company’s main production site for the drug.