AbbVie announced today that the U.S. Food and Drug Administration (FDA) has approved HUMIRA® (adalimumab) for reducing signs and symptoms, and achieving and maintaining clinical remission, in pediatric Crohn's disease patients 6 years of age and older when certain other treatments have not worked well enough. This FDA approval represents the eighth indication for HUMIRA in the United States and makes it the first and only biologic treatment approved for use in this patient population that can be administered at home.
-- HUMIRA is now indicated to treat pediatric 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
-- HUMIRA is the first biologic approved in the U.S. that can be administered at home for the treatment of moderately to severely active Crohn's disease in pediatric patients-- FDA granted HUMIRA Orphan Drug Designation for pediatric Crohn's disease
"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."
For information CLICK HERE
No comments:
Post a Comment