AbbVie has received approval from the US Food and Drug Administration (FDA) for its Humira (adalimumab) to treat paediatric patients with moderately to severely active Crohn’s disease.
The drug has been developed to reduce signs and symptoms, as well as to achieve and maintain clinical remission in paediatric Crohn’s disease patients six years of age and older.
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The approval represents the eighth indication for Humira in the US, and is the only biologic approved to treat patient population that can be administered at home.
AbbVie chief scientific officer and research and development executive vice-president Michael Severino said: "Children living with moderate to severe Crohn’s disease have limited treatment options and AbbVie is pleased that Humira will now be an available option for many of these patients.
"This approval underscores our continued commitment to innovate with Humira, both in studying potential new indications to help meet unmet medical needs and in helping to improve the standard of care for patients living with immune-mediated inflammatory diseases like Crohn’s disease."
The approval was based on the Phase III IMAgINE-1 trial, which assessed multiple dosing strategies of Humira to induce and maintain clinical remission in paediatric patients with moderately to severely active Crohn’s disease.
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By GlobalDataIn 2012, the European Commission granted approval for Humira to treat paediatric patients with aged six to 17 years with severe active Crohn’s disease.
Crohn’s disease is a type of inflammatory bowel disease (IBD), which involves the end of the small intestine and the large intestine.
Image: High magnification micrograph of Crohn’s disease. Biopsy of colon. H&E stain. Photo: courtesy of Nephron.
