AbbVie submits FDA application for subcutaneous induction use of SKYRIZI in moderate to severe Crohn’s disease, supported by Phase 3 AFFIRM trial data.
Written By: Karthik Teja Macharla, PharmD
Reviewed By: Pharmacally Editorial Team
AbbVie has submitted a supplemental application to the U.S. Food and Drug Administration seeking approval for a new subcutaneous (SC) induction dosing regimen of SKYRIZI for adults with moderately to severely active Crohn’s disease.
If approved, this approach would allow patients to initiate treatment with subcutaneous injections rather than intravenous infusion, followed by maintenance dosing every eight weeks, expanding flexibility in treatment administration.
The submission is supported by data from the Phase 3 AFFIRM trial(NCT06063967), a randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of subcutaneous risankizumab as an induction therapy. The study enrolled 289 patients, randomized in a 2:1 ratio to receive risankizumab SC or placebo, with 65% of participants having previously failed advanced therapies.
The co-primary endpoints were clinical remission, defined by a Crohn’s Disease Activity Index (CDAI) score below 150, and endoscopic response at week 12. The study reported positive outcomes on both efficacy and safety measures. Its design included a 12-week placebo-controlled induction phase, followed by a response-based treatment period through week 24, and a 52-week open-label extension in which all patients received maintenance therapy.
SKYRIZI is an interleukin-23 (IL-23) inhibitor that selectively targets the p19 subunit, a pathway associated with chronic inflammatory diseases. It was first approved in 2022 as the initial IL-23–specific therapy for Crohn’s disease and is also approved for plaque psoriasis, psoriatic arthritis, and ulcerative colitis.
Kori Wallace M.D., Ph.D., vice president, global head of immunology clinical development, AbbVie highlighted that Crohn’s disease remains a chronic and unpredictable condition with significant impact on patients’ daily lives, underscoring the company’s continued focus on advancing treatment options.
Crohn’s disease is a progressive inflammatory disorder of the gastrointestinal tract, most commonly affecting the ileum and colon, and is characterized by symptoms such as persistent diarrhea and abdominal pain. The condition affects an estimated 1 million people in the United States and can lead to serious complications, including the need for surgery, while also imposing substantial physical, emotional, and economic burdens.
AbbVie anticipates a regulatory decision from the FDA later this year. If approved, the new subcutaneous induction regimen for SKYRIZI would provide an additional administration option for patients with moderate to severe Crohn’s disease.
Reference
About the Writer
Karthik Teja Macharla, PharmD is a Pharm.D. graduate with a strong interest in clinical research, pharmacovigilance, and medical writing. In his words, he is passionate about converting complex medical information into clear, evidence-based scientific communication, committed to contributing to patient safety and advancing healthcare through accurate and impactful medical content.