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News|Articles|April 27, 2026

FDA Review Sought for Subcutaneous Risankizumab Induction in Crohn Disease

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Key Takeaways

  • AbbVie seeks to expand risankizumab Crohn disease labeling from IV induction/SC maintenance to include SC induction, with potential operational advantages for infusion capacity and patient logistics.
  • AFFIRM randomized 289 adults 2:1 to SC risankizumab or placebo, with week 12 co-primary end points of CDAI <150 and endoscopic response, and 65% advanced-therapy failures.
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AbbVie seeks FDA approval for subcutaneous risankizumab induction in adults with moderately to severely active Crohn disease.

AbbVie has submitted a supplemental application to the FDA seeking approval for subcutaneous (SC) risankizumab-rzaa (Skyrizi) as an induction therapy for adults with moderately to severely active Crohn disease.1 Currently, risankizumab is approved for Crohn disease as intravenous (IV) induction followed by SC maintenance.2

AFFIRM Trial Overview

The application is based on the phase 3 AFFIRM trial, a randomized, double-blind, placebo-controlled study of 289 adults with moderate to severe Crohn disease, including those with and without prior advanced therapy failure.

The trial assessed two co-primary endpoints at week 12:

  • Clinical remission (Crohn’s Disease Activity Index score <150)
  • Endoscopic response

Patients were randomized 2:1 to SC risankizumab or placebo, and 65% had previously failed advanced therapies. The study design included a 12-week induction phase, a treatment extension through week 24, and a 52-week open-label maintenance period.3

Data Status and Open Questions

AbbVie reported “positive” top-line results, but detailed efficacy findings have not yet been published or reviewed by the FDA. As a result, several questions remain:

  • What is the magnitude of benefit versus placebo?
  • How effective is treatment in biologic-experienced patients?

In this setting, a change in route of administration may be clinically meaningful if efficacy is preserved, particularly in terms of access and patient convenience.

  • Is SC induction comparable to IV induction?

Until full data are available, the clinical impact remains uncertain.

Mechanism and Current Indications

Risankizumab is a monoclonal antibody targeting the p19 subunit of interleukin-23 (IL-23), a cytokine involved in inflammatory pathways.2 It was approved by the FDA in 2022 for Crohn disease and is also indicated for plaque psoriasis, psoriatic arthritis, and ulcerative colitis.1,2

Treatment Context in Crohn Disease

Treatment selection in Crohn disease typically involves sequencing among TNF inhibitors, integrin antagonists, IL-12/23 or IL-23 inhibitors, and Janus kinase inhibitors.4 IL-23–targeted therapies have gained attention for their efficacy in both biologic-naive and biologic-experienced populations.

An SC induction option could offer practical benefits, including reduced reliance on infusion centers, improved convenience, and simpler logistics. However, these advantages must be balanced against efficacy, adherence, and insurance coverage considerations.

Safety Profile

The current US prescribing information includes warnings for serious infections and hypersensitivity reactions, along with the need for tuberculosis screening before treatment.2 Liver monitoring is recommended during induction therapy.

Common adverse events include upper respiratory infections, headache, joint pain, abdominal pain, injection-site reactions, and anemia. It remains unclear whether SC induction alters the safety profile compared with IV induction.

Clinical Significance

Crohn disease is a chronic, high-burden condition affecting about 1 million people in the United States. Many patients require multiple lines of therapy due to nonresponse or adverse events.

In this setting, a change in route of administration may be clinically meaningful if efficacy is preserved, particularly in terms of access and patient convenience.

Next Steps

The FDA has not yet confirmed whether it will accept the application or assign a decision timeline. Additional data from the AFFIRM trial and regulatory review materials will be needed to determine the potential role of SC induction in practice.

References

1. AbbVie. (2026, April 27). AbbVie submits regulatory application to FDA for SKYRIZI (risankizumab-rzaa) subcutaneous induction for adults with moderately to severely active Crohn’s disease. PR Newswire. https://www.prnewswire.com/news-releases/abbvie-submits-regulatory-application-to-fda-for-skyrizi-risankizumab-rzaa-subcutaneous-induction-for-adults-with-moderately-to-severely-active-crohns-disease-302753553.html

2. AbbVie Inc. (2025). SKYRIZI (risankizumab-rzaa) [package insert].

3. ClinicalTrials.gov. (2026). A study to assess adverse events and change in disease activity of risankizumab subcutaneous induction treatment for moderately to severely active Crohn’s disease. Clinicaltrials.gov. https://clinicaltrials.gov/study/NCT06063967

4. Gajendran, M., Loganathan, P., Jimenez, G., et al. (2018). A comprehensive review and update on Crohn’s disease. Disease-a-Month. https://doi.org/10.1016/j.disamonth.2017.07.001

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