AbbVie has received approval from the US Food and Drug Administration (FDA) for Humira (adalimumab) to reduce signs and symptoms as well as achieve and maintain clinical remission, in pediatric Crohn's disease patients six years of age and older.
Crohn’s disease is a type of inflammatory bowel disease (IBD) which involves the end of the small intestine and the large intestine.
The FDA approval represents the eighth indication for Humira in the US and making it the first and only biologic approved to treat these patients that can be administered at home.
Connecticut Children’s Medical Center head of the Division of Digestive Diseases, Hepatology and Nutrition Jeffrey Hyams said moderate to severe Crohn’s disease is a serious chronic disorder that can impact children and adolescents in significant ways during this important stage of their lives.
"The approval of HUMIRA for this patient population offers a new important treatment option for physicians and their patients that can help address this sometimes debilitating disease," Hyams said.
The approval was based on data from the Phase III IMAgINE-1 trial, which assessed multiple dosing strategies of Humira to induce and maintain clinical remission in pediatric patients with moderately to severely active Crohn’s disease for whom certain other treatments have not worked well enough.
The multi-center, randomized, double-blind anti-TNF IMAgINE-1 trial was carried out in patients six to 17 years of age with moderately to severely active Crohn’s disease.
This disease can appear at any age, but it is most often diagnosed in adolescents and young adults between 15 and 35 years of age.
AbbVie Research and Development executive vice president and Michael Severino said children living with moderate to severe Crohn’s disease have limited treatment options and the company is happy 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," Severino said.