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AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) approved HUMIRA® (adalimumab) for the treatment of moderately to severely active ulcerative colitis in pediatric patients 5 years of age and older. In clinical trials, HUMIRA induced clinical remission at Week 8 and maintained remission at Week 52 in patients who responded at Week 8.

“Ulcerative colitis can have a profound effect on children and for too long, treatment options for pediatric patients have been limited,” said Brandee Pappalardo, vice president and head of U.S. immunology medical affairs, AbbVie. “This approval provides the first and only subcutaneous biologic for pediatric patients with ulcerative colitis that can be administered at home. This new indication for HUMIRA demonstrates AbbVie’s commitment to patients with inflammatory bowel diseases and reinforces our goal of reducing the burden of this disease for patients.”

This approval is based on results from the pivotal Phase 3 ENVISION I study, which showed that HUMIRA achieved the co-primary endpoints of clinical remission per Partial Mayo Score (PMS) at Week 8 and, among those who responded at Week 8, clinical remission per Full Mayo Score (FMS) at one year (52 weeks). Clinical remission was defined as a PMS or as a FMS less than or equal to two and no individual sub-score greater than one.

“Ulcerative colitis is unpredictable and affects everyone, especially children, in different ways,” said Marla Dubinsky, M.D., chief, Division of Pediatric Gastroenterology for the Mount Sinai Health System and co-director of the Susan and Leonard Feinstein IBD Center at Mount Sinai. “In the ENVISION I study, HUMIRA provided clinical response as early as Week 8, and many who achieved partial Mayo score response at Week 8 achieved clinical remission at Week 52, per FMS. As a clinician, I am excited to have a new treatment option available and am encouraged by these positive results, which have the potential to help pediatric patients and their caregivers manage their disease.”

Ulcerative colitis is characterized by inflammation of the large intestine with symptoms ranging from mild to severe bowel urgency and bowel incontinence as well as weight loss and fatigue. It remains a lifelong condition that is not adequately controlled in many patients, underscoring the need for more treatment options. Significant unmet needs remain in moderate to severe pediatric ulcerative colitis, compared to adults, as pediatric patients tend to have more extensive disease often causing significant morbidity in children.