Humira Gains Pediatric Crohn's Disease Indication
AbbVie announced that the 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 for patients ≥6 years old when certain other treatments were inadequate. This marks Humira as the first biologic approved for use in this demographic that can be administered at home.
The approval was based on the Phase 3 IMAgINE-1 trial that assessed multiple dosing strategies of Humira to induce and maintain clinical remission in pediatric patients with moderately to severely active Crohn's disease. This multi-center, randomized double-blind, anti-TNF trial enrolled patients 6–17 years old.
Humira is already indicated to reduce the signs and symptoms of: moderate to severe rheumatoid arthritis (RA) in adults; moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in children ≥4 years of age; psoriatic arthritis (PsA) in adults; ankylosing spondylitis (AS) in adults; moderate to severe adult Crohn's disease (CD) and to achieve and maintain clinical remission in adults who have not responded well to conventional treatments; to induce and sustain remission in moderate to severe ulcerative colitis (UC) when certain other medicines have not worked well enough; and to treat moderate to severe chronic plaque psoriasis (Ps) in adults who are ready for systemic therapy or phototherapy.
For more information call (800) 633-9110 or visit Humira.com.