AbbVie announced that the U.S. Food and Drug Administration (FDA) has approved SKYRIZI® (risankizumab-rzaa) for adults with moderately to severely active ulcerative colitis. This milestone makes SKYRIZI the first IL-23 specific inhibitor approved for both moderate to severe ulcerative colitis and moderate to severe Crohn's disease.

The approval was based on positive outcomes from two pivotal Phase 3 clinical trials: a 12-week induction study, INSPIRE, and a 52-week maintenance study, COMMAND. Both studies demonstrated that patients achieved clinical remission and endoscopic improvement, which were the primary and key secondary endpoints, respectively.

"This approval for SKYRIZI is an important step toward addressing treatment goals of early and sustained clinical remission as well as endoscopic improvement," said Dr. Edward V. Loftus, Jr., Professor of Gastroenterology at the Mayo Clinic.

Ulcerative colitis, a form of inflammatory bowel disease affecting over 1 million people in the U.S., causes inflammation and damage to the colon lining, leading to symptoms like abdominal pain, bloody stool, and urgent bowel movements. The disease can vary significantly between patients and can lead to severe complications, including cancer or death.

"Today's approval expands our IBD portfolio and reinforces our commitment to addressing the ongoing needs of patients," said Dr. Roopal Thakkar, senior vice president, chief medical officer at AbbVie.

SKYRIZI's dosing regimen for ulcerative colitis involves a 12-week induction period with three 1200 mg doses administered every four weeks, followed by maintenance therapy with either 180 mg or 360 mg doses every eight weeks. Maintenance can be managed at home using an on-body injector (OBI), a patient-friendly device that adheres to the body and delivers medication in about five minutes.