U.S. FDA Approves Subcutaneous Induction Regimen for AbbVie's SKYRIZI® (risankizumab-rzaa) for Adults With Moderately to Severely Active Crohn's Disease
Key Highlights
- ➤FDA approves subcutaneous SKYRIZI induction for adult Crohn’s disease patients
- ➤Advanced therapy-naïve patients achieved 74% clinical remission versus 27% placebo
- ➤Advanced therapy-naïve patients achieved 60% endoscopic response versus 15% placebo
- ➤SKYRIZI induction uses an on-body injector at weeks 0, 2, 4 and 8
- ➤FDA updates TB guidance, allowing provider clinical judgment before treatment initiation
Expert Statements
Roopal Thakkar, Executive vice president, research and development, chief scientific officer, AbbVie
“People living with Crohn's disease need treatments that can deliver meaningful disease control from the start.”
Roopal Thakkar, Executive vice president, research and development, chief scientific officer, AbbVie
“With the approval of subcutaneous induction, we are building on the strong efficacy of SKYRIZI while giving patients and physicians greater flexibility in how treatment is initiated.”
Roopal Thakkar, Executive vice president, research and development, chief scientific officer, AbbVie
“This is one more example of how AbbVie continues to advance treatment to better meet the needs of people living with Crohn's disease.”
Millie D. Long, Chief, division of gastroenterology and hepatology, University of North Carolina at Chapel Hill, and lead investigator of AFFIRM
“When patients and I discuss treatment, they want to know two things: will it work? And how will it fit into their lives?”
Millie D. Long, Chief, division of gastroenterology and hepatology, University of North Carolina at Chapel Hill, and lead investigator of AFFIRM
“AFFIRM answered the first question, with superior rates of clinical remission and endoscopic response versus placebo during induction with subcutaneous SKYRIZI, particularly in patients new to advanced therapy.”
Millie D. Long, Chief, division of gastroenterology and hepatology, University of North Carolina at Chapel Hill, and lead investigator of AFFIRM
“This approval answers the second.”
Millie D. Long, Chief, division of gastroenterology and hepatology, University of North Carolina at Chapel Hill, and lead investigator of AFFIRM
“As a physician who has used the SKYRIZI OBI, I've seen firsthand the convenience it can offer patients.”
Millie D. Long, Chief, division of gastroenterology and hepatology, University of North Carolina at Chapel Hill, and lead investigator of AFFIRM
“Now with this approval, patients can start treatment at home and continue the same way through maintenance.”
U.S. FDA Approves Subcutaneous Induction Regimen for AbbVie's SKYRIZI® (risankizumab-rzaa) for Adults With Moderately to Severely Active Crohn's Disease PR Newswire
* Now with a new route of induction administration, subcutaneous SKYRIZI supports early symptomatic and endoscopic control with an on-body injector (OBI) device throughout the course of treatment * In the pivotal Phase 3 AFFIRM study, subcutaneous (SC) SKYRIZI(® )achieved superior clinical remission(i) and endoscopic response(ii) at week 12 compared with placebo in patients with Crohn's disease; results were particularly strong in patients without prior advanced therapy failure(iii) * The safety profile of subcutaneous induction was generally consistent with the established SKYRIZI profile in Crohn's disease, with no new safety risks identified * FDA also approved an update to the U.S. Prescribing Information warning and precautions across all indications to allow healthcare providers to use clinical judgment when determining whether tuberculosis (TB) testing is needed NORTH CHICAGO, Ill., Oct. 23, 2026 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced the U.S. Food and Drug Administration has approved a subcutaneous (SC) induction regimen for SKYRIZI(®) (risankizumab-rzaa) for adults with moderately to severely active Crohn's disease (CD)(iv). 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.
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