AbbVie’s Humira (adalimumab) Receives the US FDA’s Approval to Treat Pediatric Patients with Ulcerative Colitis

Shots:

• The approval is based on P-III ENVISION I study that involves assessing Humira (SC) vs PBO in pediatric patients aged 4-17yrs. with mod. to sev. UC
• The study demonstrated that 60% of patients taking the higher dosage achieved clinical remission per PMS @8wks induction period and 45% of patients who responded @8wks, achieved remission per FMS @52wks.
• Humira is the 1st and only SC biologic treatment option for pediatric patients with the mod. to sev. active UC. The approval marks the 11 indication in the US which includes 5 approval in pediatric populations

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