The tumor necrosis factor blocker adalimumab is now approved for treating children with Crohn’s disease, down to age 6 years, AbbVie, the manufacturer, announced on Sept. 25.
The approved indication is for “reducing signs and symptoms and inducing and maintaining clinical remission in patients 6 years of age and older with moderately to severely active Crohn’s disease who have had an inadequate response to corticosteroids or immunomodulators such as azathioprine, 6-mercaptopurine, or methotrexate.”
Approval of the pediatric indication was based on a phase III study of almost 200 patients aged 6-17 years with moderately to severely active disease, the IMAGINE-1 trial, the company said in the statement.
No new safety signals were seen in the study, according to the company.
As with other immunomodulators like adalimumab, the label includes a boxed warning about the increased risks of serious infections and malignancies associated with treatment, which are also explained in the adalimumab medication guide, distributed with each filled prescription.
Adalimumab is administered subcutaneously, with a maintenance dose administered every other week starting at 4 weeks, after induction doses are administered 2 weeks apart during the first month.
Adalimumab, marketed as Humira, was first approved in the United States in 2002. In Europe, it was approved for pediatric patients aged 6-17 years with severe active Crohn’s in 2012.
The updated prescribing information is available at http://www.rxabbvie.com/pdf/humira.pdf.