FDA clears at-home subcutaneous induction for AbbVie's Skyrizi in Crohn's disease

The US Food and Drug Administration approved a subcutaneous induction regimen for AbbVie's Skyrizi (risankizumab-rzaa) in adults with moderately to severely active Crohn's disease, AbbVie said on 23 October 2026 ¹. Patients can now begin the IL-23 inhibitor at home with an on-body injector induction pack and stay on the same device every eight weeks for maintenance, rather than starting with intravenous infusions ¹.

What the trial found

The approval rests on AFFIRM, a global Phase 3, randomised, double-blind, placebo-controlled study that randomised 274 adults 2:1 to subcutaneous risankizumab or placebo ¹. The population was largely treatment-refractory: 65% had already failed an advanced therapy ¹. Skyrizi beat placebo on both co-primary endpoints at week 12, clinical remission and endoscopic response ¹.

Across the whole trial, 56% of treated patients reached clinical remission against 30% on placebo, and 43% had an endoscopic response against 15% ¹. Endoscopic remission was 26% versus 11% ¹. The gap was widest in patients who had never failed an advanced therapy (65 on drug, 33 on placebo): 74% were in clinical remission against 27%, and 60% had an endoscopic response against 15% ¹. In those who had failed prior biologics or JAK inhibitors, remission was 45% against 31% ¹. AbbVie reported no new safety risks with subcutaneous induction ¹.

The approved schedule is 720 mg by on-body injector at weeks 0, 2, 4 and 8 ¹. Intravenous induction of 600 mg at weeks 0, 4 and 8 remains an option, and maintenance by injector starts at week 12 ¹.

The FDA also changed the tuberculosis wording in the warnings and precautions section across every approved Skyrizi indication ¹. The label now leaves TB evaluation before the first dose to clinical judgement, and AbbVie states that no TB test is mandatory before starting treatment ¹.

What it means for the market

The practical change is where Crohn's treatment begins. Until now the label began Skyrizi in Crohn's disease with infusions, which ties the first weeks of therapy to an infusion site. A fully self-administered course from day one removes that step for patients and prescribers in the US, and the looser TB wording takes away another pre-treatment hurdle ¹. Roopal Thakkar, AbbVie's chief scientific officer, framed the approval as giving patients and physicians "greater flexibility in how treatment is initiated" ¹.

AbbVie is also leaning on device preference to defend its position. It cites a real-world survey of 186 people with Crohn's disease in which 88% found its on-body injector easy to use, and a separate patient survey of 352 adults with inflammatory bowel disease in which 87% were satisfied with the injector against 71% with an autoinjector ¹. Both are company-cited surveys rather than trial results. The release gives no pricing, uptake forecast or timetable for filings outside the US, so the effect on payers and on competing Crohn's biologics is not yet known.

Caveats

AFFIRM is a single trial of 274 patients with a 12-week placebo-controlled primary period, and the strongest numbers come from the smaller advanced therapy-naive subgroup ¹. The data come from AbbVie's own announcement. The study continues with a second period from week 12 to 24 and a 52-week open-label extension in which all patients receive approved maintenance treatment ¹.