FDA Approves Subcutaneous Induction for AbbVie's Skyrizi in Crohn's Disease
Adults with moderately to severely active Crohn's disease can now begin AbbVie's Skyrizi with injections rather than intravenous infusions, after the U.S. Food and Drug Administration approved a subcutaneous induction regimen for the interleukin-23 inhibitor. AbbVie, based in North Chicago, Illinois, announced the decision on Oct. 23, 2026. The new regimen delivers four 720 mg doses through an on-body injector at weeks 0, 2, 4 and 8, after which patients continue on the same device every eight weeks for maintenance.
Key developments
- The FDA approved subcutaneous induction of Skyrizi (risankizumab-rzaa) at 720 mg at weeks 0, 2, 4 and 8 for adults with moderately to severely active Crohn's disease; the existing 600 mg intravenous induction at weeks 0, 4 and 8 remains available.
- Approval rests on the Phase 3 AFFIRM study, which randomized 274 adults 2:1 to subcutaneous risankizumab or placebo; 65% of participants had previously failed advanced therapies.
- At week 12, 56% of patients on subcutaneous Skyrizi reached clinical remission versus 30% on placebo, and 43% achieved endoscopic response versus 15%, with both co-primary endpoints significant at p<0.001.
- The FDA also cleared a revised tuberculosis warning across all Skyrizi indications, under which providers consider TB evaluation based on clinical judgment rather than a mandatory test before starting treatment.
- AbbVie reported no new safety risks with subcutaneous induction; the same regimen is under review by the European Medicines Agency.
Disease and treatment background
Crohn's disease is a chronic, progressive inflammatory bowel disease that most often affects the end of the small intestine and the colon. Patients typically experience persistent diarrhea and abdominal pain, and the condition can lead to complications that require surgery. Biologic drugs that block interleukin-23, a signaling protein that drives intestinal inflammation, have become a central option for patients who do not respond to conventional therapy.
Skyrizi first won FDA approval in Crohn's disease in June 2022, as the first specific IL-23 inhibitor cleared for the condition. That label required three intravenous infusions to start treatment, followed by self-administered maintenance doses through an on-body injector, a wearable device that sticks to the skin and delivers the dose. The drug is also approved for plaque psoriasis, psoriatic arthritis and ulcerative colitis.
AbbVie submitted its application for subcutaneous induction on April 27, 2026. At the American College of Gastroenterology meeting in Nashville earlier this month, the company reported week 24 AFFIRM data showing endoscopic remission in 35.8% of patients who responded at week 12 and continued on Skyrizi, compared with 9.1% on placebo.
Industry implications
The approval removes one of the main practical barriers to starting a biologic in Crohn's disease. Intravenous induction requires a patient to visit an infusion center or hospital outpatient unit three times over two months, which can delay the start of therapy while appointments are scheduled and insurance is cleared. Subcutaneous induction allows treatment to begin at home, once a patient is trained on the device.
The data also show a sharp difference by treatment history. Among patients who had never failed an advanced therapy, 74% reached clinical remission at week 12 on subcutaneous Skyrizi versus 27% on placebo. In patients who had already failed advanced therapies, the figures were 45% and 31%. That pattern supports the use of IL-23 inhibitors earlier in the treatment sequence, a positioning that both AbbVie and its rivals have pursued in gastroenterology.
For providers, the revised tuberculosis language may also simplify onboarding, since it shifts TB screening to clinical judgment. AbbVie still recommends liver blood tests before treatment, during induction and for at least 12 weeks after starting therapy.
Competitive and supply chain implications
The decision narrows a gap with Johnson & Johnson's Tremfya (guselkumab), which the FDA approved in Crohn's disease in March 2025 with both subcutaneous and intravenous induction options. J&J had marketed Tremfya as the only IL-23 inhibitor offering both routes in the disease. Skyrizi now matches that flexibility, although the dosing differs: Tremfya's subcutaneous induction uses 400 mg every four weeks for three doses, while Skyrizi's uses four 720 mg doses over eight weeks delivered by a wearable injector.
Device choice will likely become a point of differentiation. AbbVie cited a real-world survey of 186 Crohn's patients in which 88% found the on-body injector easy to use, and a company survey of 352 adults with inflammatory bowel disease in which 87% were satisfied with the device versus 71% for an autoinjector. These are company-reported surveys rather than head-to-head trials.
On the supply side, a home-based induction pack shifts volume from intravenous vials, which are typically handled by infusion sites and specialty distributors, toward prefilled cartridges dispensed through specialty pharmacies. Device and fill-finish capacity for the on-body injector system becomes more important for AbbVie as more patients start treatment this way.
Regional implications
The approval applies to the United States. AbbVie said the subcutaneous induction regimen is also under review by the European Medicines Agency, where Skyrizi is already approved for Crohn's disease with intravenous induction. In markets where infusion capacity is limited or where patients live far from specialist centers, an injection-only regimen could widen access, depending on reimbursement decisions by national payers.
In the U.S., AbbVie offers a co-pay card that can reduce monthly out-of-pocket costs to as little as $0 for eligible commercially insured patients, and a patient assistance program that provides the drug at no charge to qualifying uninsured or underinsured patients.
Credence Research analysis
This approval does not add a new patient population to Skyrizi's label, but it changes how quickly and where treatment can begin. In immunology, convenience at the start of therapy often shapes which biologic a gastroenterologist chooses for a newly eligible patient, and induction logistics have been one of the few practical distinctions between the leading IL-23 inhibitors. By matching Tremfya's dual-route option, AbbVie removes a selling point that J&J has used since 2025 and shifts the comparison toward efficacy data, safety and device experience.
The subgroup results deserve attention. The large gap between advanced therapy-naive and previously treated patients suggests the greatest benefit lies in earlier use, which places the next contest in payer formularies and step-therapy rules that often require patients to fail older drugs first. AbbVie's ability to secure earlier-line coverage, along with the European decision, will determine how much the new regimen changes prescribing in practice.
What comes next
- Launch of the subcutaneous induction pack in the U.S. and updates to prescribing information and patient training materials.
- A European Medicines Agency decision on subcutaneous induction for Crohn's disease.
- Further AFFIRM results from the 52-week open-label extension, in which all patients receive maintenance treatment.
- Payer coverage decisions on whether subcutaneous induction is covered on the same terms as intravenous induction.
- Competitive responses from other IL-23 inhibitor makers in inflammatory bowel disease.
Sources
- AbbVie: U.S. FDA Approves Subcutaneous Induction Regimen for SKYRIZI in Crohn's Disease (Oct. 23, 2026)
- AbbVie: New Phase 3 AFFIRM Data Presented at ACG 2026 (Oct. 13, 2026)
- AbbVie: Regulatory Application Submitted to FDA (April 27, 2026)
- Johnson & Johnson: FDA Approves TREMFYA in Crohn's Disease (March 20, 2025)
Image: AbbVie headquarters, by LittleT889 via Wikimedia Commons, CC BY 4.0. Cropped and edited by Credence Research.
About the Author
Senior News Editor at Credence Research Inc