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# Subcutaneous Skyrizi OK’d for At-Home Induction in Crohn’s
- URL: https://www.fdaweb.com/subcutaneous-skyrizi-okd-for-at-home-induction-in-crohns/
- Published: 2026-10-26T19:27:45.000Z
- Updated: 2026-10-26T19:27:45.000Z
- Author: David McFarland
- Tags: Biologics

FDA has approved AbbVie’s subcutaneous (SC) induction regimen for Skyrizi (risankizumab-rzaa) for adults with moderately to severely active Crohn's disease (CD). “Patients now have the option to start SKYRIZI treatment at home, with induction doses delivered by an on-body injector (OBI) induction pack and then continue using an OBI once every eight weeks throughout the course of maintenance treatment,” a company release says.

The approval was based on [positive results](https://edge.prnewswire.com/c/link/?t=0&l=en&o=4803447-1&h=3124998267&u=https%3A%2F%2Fnews.abbvie.com%2F2026-03-02-AbbVie-Announces-Positive-Topline-Results-from-Phase-3-AFFIRM-Study-Evaluating-SKYRIZI-R-Risankizumab-Subcutaneous-Induction-in-Patients-with-Crohns-Disease&a=positive+results&ref=fdaweb.com) from the Phase 3 AFFIRM trial evaluating the efficacy and safety of SC Skyrizi versus placebo in patients with moderately to severely active CD, AbbVie says. “Skyrizi achieved superiority of the co-primary endpoints of clinical remission and endoscopic response at week 12,” it adds. “Although the study enrolled a primarily treatment-refractory population, these Phase 3 results were particularly strong within patients without prior advanced therapy failure (advanced therapy-naïve).” At Week 12, 74% of advanced therapy-naïve patients were in clinical remission compared with 27% for those on placebo.