FDA Approves SKYRIZI for Ulcerative Colitis, Expanding AbbVie's IBD Portfolio

In a significant advancement for the treatment of inflammatory bowel diseases, AbbVie has 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 ulcerative colitis and Crohn's disease, expanding its use across four indications for immune-mediated inflammatory diseases.

The approval of SKYRIZI for ulcerative colitis is based on positive results from two Phase 3 clinical trials: the 12-week induction study, INSPIRE, and the 52-week maintenance study, COMMAND. The primary endpoint for both studies was clinical remission, which was successfully achieved along with significant endoscopic improvement, a critical secondary endpoint.

Dr. Edward V. Loftus, Jr. from Mayo Clinic emphasized the importance of attaining both early and sustained clinical remission as well as endoscopic improvement in treating ulcerative colitis. He described the approval as an essential step toward these treatment goals.

Ulcerative colitis affects over 1 million people in the United States and is characterized by inflammation in the digestive tract, which can lead to colon damage. Patients often suffer from symptoms like abdominal pain, bloody stools, and an urgent need to use the bathroom. The disease can also lead to severe complications, including surgery, cancer, or even death.

Dr. Roopal Thakkar, AbbVie's chief medical officer, expressed that the approval of SKYRIZI furthers their commitment to addressing the needs of patients with inflammatory bowel diseases through continued investment in innovative treatments.

The dosing regimen for SKYRIZI in treating ulcerative colitis begins with a 12-week induction period, involving three 1200 mg doses administered every four weeks. Maintenance therapy follows with doses of either 180 mg or 360 mg every eight weeks. After the induction period, the treatment can be administered at home using an on-body injector, a device designed for patient convenience.

While effective, SKYRIZI can cause serious side effects, including severe allergic reactions, increased risk of infections, and liver problems. Patients are advised to seek immediate medical attention if they experience symptoms of a serious allergic reaction. Additionally, doctors should monitor patients for infections and liver issues before and during treatment.

AbbVie is also committed to ensuring patient access to SKYRIZI through support programs, such as offering a co-pay card that can reduce out-of-pocket costs for eligible patients. For those without insurance, AbbVie's assistance program provides the medication at no charge to qualifying individuals.

SKYRIZI is part of a collaboration between AbbVie and Boehringer Ingelheim, with AbbVie leading its global development and commercialization. The drug is an interleukin-23 (IL-23) inhibitor that works by selectively blocking the p19 subunit of IL-23, a cytokine involved in inflammatory processes linked to several chronic immune-mediated diseases.

AbbVie’s robust clinical trial program highlights their dedication to advancing treatments for inflammatory bowel diseases, aiming to improve the quality of life for those affected. With the approval of SKYRIZI for ulcerative colitis, the company continues to innovate and address the evolving needs of patients.