Abbott files Humira for childhood RA and IA

USA-based health care major Abbott Laboratories says it has completed the simultaneous submission of both a supplemental Biologics License Application and a Type II Variation document with regulators on both sides of the Atlantic, requesting approval to market Humira (adalimumab) for the treatment of juvenile rheumatoid arthritis and juvenile idiopathic arthritis. The company added that the filings are the first time it has sought clearance for the drug in a pediatric indication.

The firm explained that the global filing includes data from a Phase III 48-week study that enrolled 171 children suffering from polyarticular JRA. In the first stage of the study, patients were split on the basis of their use, or not, of methotrexate, before being treated with a subcutaneous dose of the drug every other week for 4 months. Those that showed a positive clinical response were randomized to receive Humira or placebo for a further 32-weeks or until they experienced a disease flare.

The findings showed that treatment resulted in fewer flares when compared with placebo, both with (37% versus 65%) and without (43% vs 71%) additional methotrexate therapy. Furthermore, nearly twice the number of patients receiving Humira achieved 70% improvements in American College of Rheumatology Pediatric disease criteria, compared with those in the placebo group (56% vs 28%).