FDA News

FDA approves Humira for pediatric patients with Crohn’s disease

The FDA has approved adalimumab for the treatment of moderately to severely active pediatric Crohn’s disease in patients for whom other therapies had inadequate results, according to a company press release.

“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,” Jeffrey S. Hyams, MD, head of the division of digestive diseases, hepatology and nutrition, Connecticut Children’s Medical Center, said in the release. “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.”

The approval of adalimumab (Humira, Abbvie) now indicates it for patients aged 6 years and older for reducing signs and symptoms of Crohn’s disease, and achieving and maintaining clinical remission for patients who experienced inadequate response to immunomodulators or corticosteroids, the release said. The approval makes adalimumab the first biologic for this patient population that is approved for at-home administration, according to Abbvie.

“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,” Michael Severino, MD, executive vice president of research and development, chief scientific officer of Abbvie, said in the release. “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 FDA approval follows results from the phase 3 IMAgINE-1 trial, the largest multicenter, randomized, double blind trial to date of tumor necrosis factor-alpha inhibitors in patients aged 6 to 17 years with moderate to severe Crohn’s disease.

The FDA has approved adalimumab for the treatment of moderately to severely active pediatric Crohn’s disease in patients for whom other therapies had inadequate results, according to a company press release.

“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,” Jeffrey S. Hyams, MD, head of the division of digestive diseases, hepatology and nutrition, Connecticut Children’s Medical Center, said in the release. “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.”

The approval of adalimumab (Humira, Abbvie) now indicates it for patients aged 6 years and older for reducing signs and symptoms of Crohn’s disease, and achieving and maintaining clinical remission for patients who experienced inadequate response to immunomodulators or corticosteroids, the release said. The approval makes adalimumab the first biologic for this patient population that is approved for at-home administration, according to Abbvie.

“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,” Michael Severino, MD, executive vice president of research and development, chief scientific officer of Abbvie, said in the release. “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 FDA approval follows results from the phase 3 IMAgINE-1 trial, the largest multicenter, randomized, double blind trial to date of tumor necrosis factor-alpha inhibitors in patients aged 6 to 17 years with moderate to severe Crohn’s disease.