FDA Approves Option for Pediatric Ulcerative Colitis
The FDA has approved Humira (Adalimumab) for the treatment of moderately to severly active ulcerative colitis (UC) in pediatric patients aged 5 years or older. This makes Humira the first and only subcutaneous biologic treatment option for this patient population.
The approval is based upon the results of a Phase 3 study in which 60% of patients receiving Humira achieved clinical remission of UC as measured by the Partial Mayo Score at week 8, of whom 45% achieved remission per Full Mayo Score at week 52.
The most common adverse effects included injection site reaction, upper respiratory infection, headache, rash, 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