AbbVie announced on April 27 that it has submitted a regulatory application to the U.S. Food and Drug Administration seeking approval for subcutaneous induction of SKYRIZI (risankizumab-rzaa) in adults with moderately to severely active Crohn’s disease.
This submission could provide patients with an additional option beyond the currently approved intravenous induction method. The company said the application is supported by positive results from the Phase 3 AFFIRM study, which evaluated risankizumab as an induction treatment in adults with moderately to severely active Crohn’s disease, including those who had not responded to previous advanced therapies.
“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 at 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.”
If approved, adult patients would have a choice between subcutaneous injection or intravenous infusion for their SKYRIZI induction therapy before continuing maintenance dosing every eight weeks. SKYRIZI was first approved by the FDA in 2022 as an interleukin-23 specific inhibitor for this patient group.
The AFFIRM study enrolled 289 participants and assessed clinical remission and endoscopic response after twelve weeks of treatment. More information about this trial can be found at ClinicalTrials.gov.
According to the official website, AbbVie delivers products to patients in more than 175 countries and has over 55,000 employees across its operations worldwide. The company maintains staff presence in more than 70 countries and develops therapies addressing over 75 conditions, serving approximately 60 million people each year according to its official website. AbbVie operates within the biopharmaceutical sector with research focused on immunology, oncology, neuroscience, and other key areas.
SKYRIZI is also approved by both U.S. and European regulators for treating plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis.
