Abbott debuts pediatric Humira in UK; gets US FDA appro for first infant-specific dosage for Creon

US health care major Abbott Laboratories (NYSE: ABT) has launched a pediatric vial of its blockbuster rheumatoid arthritis drug Humira (adalimumab) in the UK, which means the youngest population yet can benefit from treatment.

Following European approval in March, Humira is now indicated for the treatment of active polyarticular juvenile idiopathic arthritis (JIA) in UK patients from as young as four. Previously, Abbott’s flagship biologic - which generated 2010 sales of $6.5 billion - held a JIA licence for use only in eligible patients aged 13-17.

The licence extension states Humira in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in children and adolescents aged four to 17 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). Humira can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. The drug has not been studied in children aged less than four years.1