Crohn's patients beginning AbbVie's Skyrizi have until now started treatment with intravenous doses. Under a newly approved regimen, they can take their first injections at home with an on-body injector and use the device for maintenance every eight weeks, AbbVie said Friday. The FDA also loosened the label's tuberculosis-testing language across all indications.
The approval rests on AFFIRM, a Phase 3 trial that tested the injections against placebo over 12 weeks in a mostly treatment-refractory population. Among patients who had never failed an advanced therapy, 74% reached clinical remission at week 12 versus 27% on placebo, and endoscopic response was roughly four times higher than placebo, the company said. No new safety risks were observed. Responses were lower but still above placebo in patients who had already exhausted biologics or JAK inhibitors.
The commercial stakes are large. Skyrizi has become the engine of AbbVie's immunology business, its second-quarter results show. Humira, meanwhile, is losing ground to biosimilars.
The decision also sharpens a rivalry in IL-23 inhibitors for the gut. Johnson & Johnson's Tremfya has offered Crohn's patients a fully subcutaneous start since March 2025. The FDA cleared it that month with both injection and infusion induction options, J&J said at the time. Tremfya's Crohn's approval followed its ulcerative colitis clearance and marked the drug's fourth U.S. indication.