U.S. FDA approves subcutaneous induction for AbbVie's SKYRIZI in Crohn's disease

On October 23, 2026, AbbVie said the U.S. Food and Drug Administration approved a subcutaneous induction regimen for SKYRIZI (risankizumab-rzaa) for adults with moderately to severely active Crohn's disease. Patients can now start treatment at home, with induction doses delivered by an on-body injector (OBI) induction pack. They then continue with an OBI once every eight weeks during maintenance treatment.

The approval is supported by the Phase 3 AFFIRM trial, which randomized 274 patients in a 2:1 ratio to subcutaneous SKYRIZI or placebo. AbbVie said subcutaneous SKYRIZI achieved superior clinical remission and endoscopic response at week 12 compared with placebo, meeting both co-primary endpoints. In patients without prior advanced therapy failure, 74% reached clinical remission, versus 27% on placebo, and 60% reached endoscopic response, versus 15% on placebo.

AbbVie said the safety profile of subcutaneous induction was generally consistent with the established SKYRIZI profile in Crohn's disease, with no new safety risks identified. The FDA also approved an update to the warnings and precautions across all indications. The revised label advises healthcare providers to consider tuberculosis evaluation before treatment based on clinical judgment, and there is no mandatory TB test before starting SKYRIZI.

Roopal Thakkar, M.D., AbbVie's executive vice president, research and development and chief scientific officer, said the approval gives patients and physicians greater flexibility in how treatment is started.