AbbVie has submitted an application to the US 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).

Kori Wallace, M.D., Ph.D., Vice President, Global Head of Immunology Clinical Development, AbbVie, said, "Crohn's disease is a chronic inflammatory condition that affects an estimated one million Americans, and its impact often reaches beyond the gut as its unpredictability can impact daily life and emotional health for patients. 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."

The application to the FDA is supported by the recently shared positive data from the Phase 3 AFFIRM study (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.

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.

Crohn's Disease is a chronic, systemic disease that manifests as inflammation within the gastrointestinal tract, most commonly in the area between the small intestine (ileum) and the colon, causing persistent diarrhea and abdominal pain. It is a progressive disease, meaning it gets worse over time and may lead to life-threatening complications or surgery.

AFFIRM is a global, Phase 3, randomised, placebo-controlled, double-blind study to evaluate the efficacy and safety of risankizumab subcutaneous (SC) as an induction treatment in adult patients with moderately to severely active Crohn's disease. Co-primary endpoints were achievement of CDAI Clinical Remission (CDAI < 150) and achievement of endoscopic response at week 12. A total of 289 patients were randomised in a 2:1 ratio to risankizumab SC or placebo. Key demographics and baseline characteristics were generally balanced between the risankizumab SC and placebo groups; 65 percent had previously failed advanced therapies for the treatment of CD.

The study consists of three treatment periods: a placebo-controlled Period A (baseline to week 12) to evaluate the efficacy and safety of risankizumab SC induction treatment, an extended Period B (week 12 to 24) where patients receive blinded or open-label treatments based on their clinical response at week 12, and a 52-week open-label extension Period C where all patients receive the approved risankizumab maintenance treatment. SKYRIZI is an interleukin (IL)-23 inhibitor that selectively blocks IL-23 by binding to its p19 subunit. IL-23, a cytokine involved in inflammatory processes, is thought to be linked to a number of chronic immune-mediated diseases. It is approved by the FDA and the European Medicines Agency (EMA) for the treatment of plaque psoriasis, psoriatic arthritis, CD and Ulcerative Colitis (UC).