AbbVie’s SKYRIZI wins FDA approval for ulcerative colitis treatment

The U.S. Food and Drug Administration (FDA) has approved SKYRIZI (risankizumab-rzaa), an interleukin-23 (IL-23) inhibitor developed by AbbVie, for the treatment of adults with moderately to severely active ulcerative colitis. This marks a significant milestone as SKYRIZI becomes the first IL-23 specific inhibitor approved for this condition, in addition to its approval for moderate to severe Crohn’s disease.

Edward V. Loftus, Jr., M.D., a gastroenterology expert from the Mayo Clinic, emphasized the importance of this approval, noting its role in achieving early and sustained clinical remission and endoscopic improvement for patients. With over a million people in the United States suffering from ulcerative colitis, the impact of this new treatment option is substantial. The disease, part of the broader category of inflammatory bowel diseases (IBD), leads to significant symptoms like abdominal pain, bloody stools, and urgent bowel movements that severely affect the quality of life.

SKYRIZI’s treatment involves a 12-week induction period followed by a maintenance therapy that can be administered at home using an innovative on-body injector (OBI), designed to ease the treatment process for patients.

Despite its benefits, SKYRIZI carries warnings against use by those allergic to its components and notes possible serious side effects such as allergic reactions, infection risks, and liver issues. The development and commercialization of SKYRIZI is a collaborative effort between Boehringer Ingelheim and AbbVie, showcasing a partnership aimed at advancing care in the realm of immune-mediated inflammatory diseases.

According to Roopal Thakkar, M.D., senior vice president at AbbVie, the approval of SKYRIZI underscores the company’s ongoing commitment to enhancing the treatment landscape for IBD patients. This is part of AbbVie’s broader strategy to address the needs of patients with chronic immune-mediated diseases through innovative solutions.