Drug Approval
AbbVie seeks FDA nod for subcutaneous SKYRIZI induction in Crohn’s disease
The submission is backed by positive results from the Phase 3 AFFIRM study
- By IPP Bureau
| April 28, 2026
Global pharma powerhouse AbbVie has filed with the US FDA seeking approval for a new subcutaneous induction option of SKYRIZI (risankizumab-rzaa) for adults with moderately to severely active Crohn’s disease.
The submission is backed by positive results from the Phase 3 AFFIRM study, which evaluated the safety and efficacy of subcutaneous risankizumab as an induction therapy, including in patients who had previously failed advanced treatments.
“Crohn's disease is a chronic inflammatory condition that affects an estimated 1 million Americans, and its impact often reaches beyond the gut as its unpredictability can impact daily life and emotional health for patients,” said Kori Wallace, vice president, global head of immunology clinical development, AbbVie.
“AbbVie continues to invest in research and innovative solutions to help elevate the standard of care for patients so that they may live a life unburdened by their Crohn's disease.”
SKYRIZI, first approved in 2022 as the first IL-23 specific inhibitor for Crohn’s disease, could soon offer patients a new route for starting therapy. If approved, patients would be able to begin treatment with a subcutaneous injection instead of intravenous infusion, before continuing maintenance dosing every eight weeks.
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