Health
AbbVie Submits Regulatory Application to FDA for SKYRIZI® (risankizumab-rzaa) Subcutaneous Induction for Adults with Moderately to Severely Active Crohn's Disease
AbbVie (NYSE: ABBV) today announced that it has submitted an application to the U.S. Food and Drug Administration (FDA) seeking approval for SKYRIZI® (risankizumab-rzaa) for subcutaneous (SC) induction for the treatment of adult patients with moderately to severely active Crohn's disease (CD).
About this update from Abbvie Inc.
[{"type":"list","items":[{"val":[{"type":"text","content":"Submission supported by data from Phase 3 pivotal AFFIRM study ","length":62,"tagName":"p"}]},{"val":[{"type":"text","content":"If approved, adult Crohn's disease patients will have an additional option for induction of risankizumab-rzaa which is already approved for intravenous (IV) induction","length":170,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":232,"olType":false},{"type":"text","content":"NORTH CHICAGO, Ill., April 27, 2026 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that it has submitted an application to the U.S. Food and Drug Administration (FDA) seeking approval for SKYRIZI® (risankizumab-rzaa) for subcutaneous (SC) induction for the treatment of adult patients with moderately to severely active Crohn's disease (CD).","length":350,"tagName":"p"},{"type":"text","content":""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, M.D., Ph.D., 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."","length":539,"tagName":"p"},{"type":"text","content":"The application to the FDA is supported by the recently shared positive data from the Phase 3 AFFIRM study1 (NCT06063967), which evaluated the efficacy and safety of risankizumab SC as an induction treatment in adult patients with moderately to severely active CD, including both those with and without prior advanced therapy failure.","length":334,"tagName":"p"},{"type":"text","content":"In 2022, SKYRIZI became the first interleukin-23 (IL-23) specific inhibitor approved by the FDA to treat adults with moderately to severely active CD. AbbVie anticipates FDA approval for this new dosing regimen for SKYRIZI later this year. If approved, patients with moderately to severely active CD would have a choice to receive their SKYRIZI induction via SC injection or through IV infusion and then continue subcutaneous maintenance dosing every eight weeks.","length":463,"tagName":"p"},{"type":"text","content":"About C...