FDA approves new indication for Humira

NORTH CHICAGO, Ill. — AbbVie on Thursday announced that the Food and Drug Administration approved Humira (adalimumab) as a treatment for pediatric Crohn's disease patients ages 6 years and older when other treatments haven't worked well enough. The agency's approval marks the eighth indication for the drug in the United States.

 

"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," said Jeffrey S. Hyams, M.D., head, division of digestive diseases, hepatology and nutrition, Connecticut Children's Medical Center. "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."

 

Humira can be self-administered after proper injection training and with appropriate physician monitoring.