FDA Approves AbbVie's Skyrizi for Adult Ulcerative Colitis

AbbVie’s interleukin-23 (IL-23) inhibitor, Skyrizi (risankizumab-rzaa), has received approval from the US Food and Drug Administration (FDA) for treating adults with moderately to severely active ulcerative colitis (UC). This condition, affecting over a million individuals in the United States, is a form of inflammatory bowel disease (IBD) that leads to inflammation in the digestive tract, potentially causing damage to the colon lining. UC is marked by unpredictable and varied symptoms such as abdominal pain, bloody stools, and an urgent need to use the bathroom. In some cases, complications can arise, including cancer.

Skyrizi operates by selectively inhibiting IL-23, a cytokine implicated in various chronic immune-mediated conditions. Previously, this medication had already been approved in the US for treating plaque psoriasis, psoriatic arthritis, and Crohn’s disease. For ulcerative colitis, the treatment regimen involves a 12-week induction phase, during which patients receive three 1200mg doses every four weeks. After this period, maintenance doses of either 180mg or 360mg are administered every eight weeks. Patients can self-administer the maintenance doses at home using an on-body injector.

The recent FDA approval was largely based on successful outcomes from two late-stage clinical trials. The INSPIRE study focused on evaluating the safety and effectiveness of a 1200mg intravenous dose of Skyrizi administered every four weeks as an induction therapy in patients with moderately to severely active UC. Another crucial study, the COMMAND trial, examined the use of 180mg or 360mg subcutaneous doses of Skyrizi as a maintenance treatment over a 52-week period in adults with the same condition. Both studies achieved their primary objective of clinical remission and met the critical secondary goal of endoscopic improvement.

Edward Loftus from the Mayo Clinic’s division of gastroenterology and hepatology in Rochester, US, emphasized the significance of the approval, stating, “When treating patients with UC, it’s important to prioritize both early and sustained clinical remission as well as endoscopic improvement. This approval for Skyrizi is an important step toward addressing these treatment goals.”

This recent authorization follows closely on the heels of a high-profile agreement between AbbVie and FutureGen Biopharmaceutical. The deal, valued at $1.7 billion, grants AbbVie an exclusive global license to develop, manufacture, and commercialize a pre-clinical therapy for IBD, identified as FG-M701. This candidate therapy is anticipated to offer enhanced efficacy and reduced dosing frequency for patients, representing another significant advancement in the treatment of inflammatory bowel diseases.