Adalimumab approval sought

Thursday 10th May 2007

US drug firm Abbott Laboratories is hoping to expand the indications for its anti-inflammatory drug Humira® (adalimumab) and has filed for paediatric approvals in Europe and the USA.

The company has simultaneously submitted a supplemental Biologics License Application with the FDA and a Type II Variation with the EMEA seeking approval to market Humira as a treatment for juvenile idiopathic arthritis (or juvenile rheumatoid arthritis as it is referred to in the USA), marking the first paediatric indication sought for Humira.

JIA is the most common form of arthritis in children and normally begins before the age of 16, the company notes. Typical symptoms include persistent joint pain and stiffness that are usually worse in the morning or after a nap and 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 JIA due to an affected knee. Dr Daniel Lovell, of Cincinnati Children's Hospital Medical Center, said that if left untreated, JIA could slow a child's growth and cause disability into adulthood.

The filings are based on the results of a phase III, 48-week study that included 171 children (aged four to 17) with polyarticular JIA, a form of arthritis affecting five or more joints. In the first part of the study, one group of patients taking methotrexate (MTX) and another group not doing so received Humira subcutaneously every other week for 16 weeks. A total of 133 children who showed a positive clinical response entered the second part of the study and they had significantly fewer disease flares than children on placebo, both without MTX (43% versus 71%) and with MTX (37% versus 65%).

Additionally, twice as many children on Humira achieved ACR Ped 70 (that is, a 70% improvement in JIA symptoms deemed important by the American College of Rheumatology) compared with those on placebo (56% versus 28%, respectively) at week 48. Further data will be submitted from an ongoing open-label extension study evaluating Humira's long-term efficacy and safety.

Humira is currently being studied in paediatric Crohn's disease and Abbott plans to initiate trials for paediatric and adolescent psoriasis later this year.

PharmaTimes 9/5/2007