FDA Approves Humira for Treatment of Pediatric Patients With Ulcerative Colitis
The US Food and Drug Administration (FDA) approved Humira (adalimumab) to treat pediatric patients aged 5 and older with moderate to severe ulcerative colitis.
The FDA approval follows the results of the pivotal Phase 3 ENVISION I study, in which 60% of pediatric patients receiving treatment with adalimumab achieved clinical remission per Partial Mayo Score (PMS) at week 8. Among those who responded at week 8, 45% also experienced clinical remission based on a Full Mayo Score (FMS) less than or equal to 2 and no individual subscore greater than 1—at 1 year (52 weeks).
No new safety signals for adalimumab were observed during the study. The most commonly reported adverse events included headache, upper respiratory infection, and nausea.
HUMIRA® (adalimumab) receives FDA approval to treat pediatric patients living with moderately to severely active ulcerative colitis. News release. Abbvie. February 24, 2021. https://news.abbvie.com/news/press-releases/humira-adalimumab-receives-fda-approval-to-treat-pediatric-patients-living-with-moderately-to-severely-active-ulcerative-colitis.htm?view_id=3806 Accessed February 25, 2021.