AbbVie’s Skyrizi Gains FDA Approval for At-Home Subcutaneous Induction in Crohn’s Disease

AbbVie announced that the FDA approved a subcutaneous (SC) induction regimen for risankizumab-rzaa (Skyrizi, AbbVie) for adults with moderately to severely active Crohn's disease (CD). Induction doses are delivered by an on-body injector (OBI) induction pack, and patients can continue OBI dosing every 8 weeks during maintenance.

Risankizumab is an interleukin-23 inhibitor that selectively binds the cytokine's p19 subunit. The SC induction regimen is 720mg by OBI at weeks 0, 2, 4, and 8. Intravenous induction with 600mg at weeks 0, 4, and 8 remains an option, and OBI maintenance dosing begins at week 12.

Approval was based on the phase 3, randomized, double-blind, placebo-controlled AFFIRM trial, which randomized 274 adults 2:1 to SC risankizumab or placebo; 65% had previously failed advanced therapy. SC risankizumab met both co-primary endpoints at week 12: clinical remission (Crohn's Disease Activity Index score <150) occurred in 56% of patients vs 30% with placebo, and endoscopic response in 43% vs 15%. Endoscopic remission, a secondary endpoint, occurred in 26% vs 11%.

Among patients without prior advanced therapy failure, clinical remission rates were 74% vs 27% and endoscopic response rates were 60% vs 15%. Among those with prior failure, rates were 45% vs 31% and 33% vs 15%, respectively. AbbVie said the safety profile of SC induction was generally consistent with risankizumab's known profile in CD, with no new safety risks identified.

The FDA also approved a labeling update across all Skyrizi indications advising clinicians to consider tuberculosis evaluation before treatment initiation based on clinical judgment. Safety information in the release includes warnings for serious allergic reactions, infections, and liver problems during treatment for CD or ulcerative colitis.

Source: AbbVie. U.S. FDA approves subcutaneous induction regimen for AbbVie's Skyrizi (risankizumab-rzaa) for adults with moderately to severely active Crohn's disease. News release. AbbVie; October 23, 2026. Accessed October 27, 2026.