North Chicago, Illinois, USA, October 23, 2026
AbbVie has received U.S. Food and Drug Administration (FDA) approval for a subcutaneous induction regimen of SKYRIZI® (risankizumab-rzaa) for adults with moderately to severely active Crohn’s disease. The approval introduces an additional treatment initiation option that allows eligible patients to begin therapy using an on-body injector (OBI) rather than requiring intravenous induction. SKYRIZI is an interleukin-23 (IL-23) inhibitor already approved for several immune-mediated conditions, including Crohn’s disease. The newly approved regimen is supported by results from the Phase 3 AFFIRM clinical trial, which demonstrated significant improvements in clinical remission and endoscopic response compared with placebo at Week 12. The decision marks an important development in inflammatory bowel disease treatment by combining clinical efficacy with greater flexibility in how patients start and continue therapy.
Phase 3 AFFIRM Trial Demonstrates Clinical Improvement
The FDA approval was supported by the Phase 3 AFFIRM study, a randomized, placebo-controlled clinical trial evaluating the efficacy and safety of subcutaneous risankizumab as induction treatment in adults with moderately to severely active Crohn’s disease. The study assessed two co-primary endpoints at Week 12: clinical remission, measured using the Crohn’s Disease Activity Index, and endoscopic response, assessed through improvements in visible intestinal inflammation. In the overall study population, 56% of patients receiving subcutaneous SKYRIZI achieved clinical remission, compared with 30% receiving placebo. Endoscopic response was achieved by 43% of patients treated with SKYRIZI, compared with 15% in the placebo group. Results were particularly encouraging among patients who had not previously experienced failure with advanced therapies. In this subgroup, 74% achieved clinical remission compared with 27% receiving placebo, while 60% achieved an endoscopic response compared with 15% in the placebo group. Endoscopic remission, an additional measure of improvement in intestinal inflammation, was also higher with SKYRIZI than placebo. These findings indicate that subcutaneous induction can provide meaningful improvements in disease activity, although individual treatment responses may vary.
At-Home Injection Offers Greater Treatment Flexibility
A key feature of the FDA approval is the ability to start SKYRIZI treatment at home using an on-body injector. Under the newly approved induction regimen, patients receive 720 mg subcutaneously at Weeks 0, 2, 4 and 8 using the OBI induction pack. Maintenance treatment begins at Week 12, with administration every eight weeks using the on-body injector. Patients may also initiate treatment through the established intravenous induction regimen, which uses 600 mg at Weeks 0, 4 and 8, followed by approved maintenance treatment. The availability of two induction routes gives healthcare providers and patients additional flexibility when selecting an appropriate treatment approach. An on-body injector delivers medication through a device attached to the skin, potentially reducing the need for repeated infusion-center visits. The option may be especially relevant for people managing a chronic condition that requires ongoing treatment and monitoring. The new regimen extends the convenience of at-home administration from maintenance treatment to the induction phase, while preserving the importance of medical supervision, appropriate patient selection and adherence to prescribing instructions.
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IL-23 Inhibition and Updated Safety Guidance
SKYRIZI works by selectively binding to the p19 subunit of interleukin-23 (IL-23), a cytokine involved in inflammatory signaling and immune-mediated disease. By inhibiting IL-23 activity, risankizumab helps reduce inflammation associated with Crohn’s disease. Crohn’s disease is a chronic inflammatory bowel disease that can cause abdominal pain, persistent diarrhea, fatigue and complications affecting the digestive tract. The condition can fluctuate between periods of active inflammation and remission, making sustained disease control an important treatment objective. The FDA also approved an update to SKYRIZI’s U.S. prescribing information concerning tuberculosis evaluation before treatment. The revised language allows healthcare providers to use clinical judgment when determining whether TB testing is needed, rather than requiring testing in every case. The safety profile of subcutaneous induction in AFFIRM was generally consistent with the established safety profile of SKYRIZI, with no new safety risks identified in the study. Important risks still include infections and serious allergic reactions, and liver-related monitoring is relevant for patients receiving treatment for inflammatory bowel disease. The approval strengthens AbbVie’s Crohn’s disease treatment portfolio by expanding administration options, while ongoing clinical care and safety monitoring remain essential.
Source: AbbVie press release
