AbbVie Wins Approval for At-Home 720 mg SKYRIZI Induction Dosing

Key Facts

AbbVie said on October 23, 2026, that the U.S. Food and Drug Administration approved a subcutaneous induction regimen of SKYRIZI for adults with moderately to severely active Crohn’s disease. The decision allows patients to begin treatment at home using an on-body injector kit, then continue with the same injector during maintenance. Induction doses are 720 mg at weeks 0, 2, 4 and 8. Maintenance dosing begins at week 12 and is then given once every 8 weeks. AbbVie said the regimen adds an option for starting treatment with subcutaneous injections.

The approval was based on the Phase 3 AFFIRM study, which randomly assigned 274 patients in a 2-to-1 ratio to subcutaneous risankizumab or placebo. Advanced therapy had previously failed in 65% of participants. In the overall study population, 56% of patients who received SKYRIZI achieved clinical remission at week 12, compared with 30% in the placebo group. Endoscopic response was 43% with treatment versus 15% with placebo. AbbVie reported these results among the study data supporting its regulatory filing.

Results were stronger among patients who had not previously failed an advanced therapy: 74% achieved clinical remission with SKYRIZI versus 27% with placebo at week 12. Endoscopic response reached 60% in the treatment group, compared with 15% in the placebo group. AbbVie had announced preliminary study results on March 2, 2026, showing clinical remission measured by the CDAI in 55% of patients versus 30% with placebo, and endoscopic response in 44% versus 14%. These preliminary figures differ from the detailed results the company later reported for the groups in its approval announcement. In April, the company said its filing with the FDA was based on Phase 3 AFFIRM data.

AbbVie said the safety profile of subcutaneous induction was generally consistent with the known profile of SKYRIZI in Crohn’s disease patients, and no new safety risks were identified. The approval also included updated warnings and precautions in the label for all indications. Under the update, health care providers may determine whether tuberculosis testing is needed based on clinical judgment. The company’s label states: "Mandatory tuberculosis testing before starting SKYRIZI is not required." The change gives physicians flexibility to determine whether to screen before treatment based on clinical assessment.

The FDA had previously approved SKYRIZI in 2022 to treat adults with moderately to severely active Crohn’s disease, and AbbVie said at the time that it was the first selective interleukin-23 inhibitor for this indication. The company estimates that the chronic disease affects about 1 million Americans and can affect daily life and mental health. Commercially, SKYRIZI recorded global revenue of $17.562 billion in 2025, a reported increase of 49.9% from the previous year. In the second quarter of 2026, revenue was $5.505 billion, up a reported 24.4% year over year. AbbVie shares closed at $284.89 on October 22, 2026.

Before the approval, AbbVie had said the study included a 52-week open-label extension period, during which all patients receive approved risankizumab maintenance treatment. This period follows the initial assessment and follow-up phases in AFFIRM. The approval announcement came after the company submitted its regulatory filing on April 27, 2026, based on the study results. Under the approved regimen, induction begins with subcutaneous doses, followed by maintenance every 8 weeks starting at week 12. The approval announcement did not specify when results from the extension period would be updated.