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Adalimumab approval sought


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

The company hassimultaneously submitted a supplemental Biologics License Applicationwith the FDA and a Type II Variation with the EMEA seeking approval tomarket Humira as a treatment for juvenile idiopathic arthritis (orjuvenile rheumatoid arthritis as it is referred to in the USA), markingthe first paediatric indication sought for Humira.

JIA isthe most common form of arthritis in children and normally beginsbefore the age of 16, the company notes. Typical symptoms includepersistent joint pain and stiffness that are usually worse in themorning or after a nap and the pain may limit movement of the affectedjoint, although many children will not complain of the pain. Walkingwith a limp is an early sign of JIA due to an affected knee. Dr DanielLovell, of Cincinnati Children’s Hospital Medical Center, said that ifleft untreated, JIA could slow a child’s growth and cause disabilityinto adulthood.

The filings are based on the results of aphase III, 48-week study that included 171 children (aged four to 17)with polyarticular JIA, a form of arthritis affecting five or morejoints. In the first part of the study, one group of patients takingmethotrexate (MTX) and another group not doing so received Humirasubcutaneously every other week for 16 weeks. A total of 133 childrenwho showed a positive clinical response entered the second part of thestudy and they had significantly fewer disease flares than children onplacebo, both without MTX (43% versus 71%) and with MTX (37% versus65%).

Additionally, twice as many children on Humiraachieved ACR Ped 70 (that is, a 70% improvement in JIA symptoms deemedimportant by the American College of Rheumatology) compared with thoseon placebo (56% versus 28%, respectively) at week 48. Further data willbe submitted from an ongoing open-label extension study evaluatingHumira’s long-term efficacy and safety.

Humira is currentlybeing studied in paediatric Crohn’s disease and Abbott plans toinitiate trials for paediatric and adolescent psoriasis later thisyear.

PharmaTimes 9/5/2007


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