AbbVie submitted a supplemental Biologics License Application (sBLA) to the US FDA seeking approval for Skyrizi (risankizumab-rzaa) as a subcutaneous induction regimen for adults with moderately to severely active Crohn's disease. The filing, announced on April 27, 2026, represents the first regulatory submission seeking to extend risankizumab's induction route beyond intravenous infusion, a step that would allow patients to receive both induction and maintenance therapy via subcutaneous injection.
The application seeks approval for a subcutaneous induction regimen in the same adult Crohn's disease population for which risankizumab already carries US FDA authorization. Under the existing approved regimen, patients receive intravenous induction doses at weeks 0, 4, and 8, before transitioning to subcutaneous maintenance dosing every eight weeks. If the new filing is accepted and approved, patients would have the option to receive their induction doses subcutaneously, removing the requirement for infusion center visits during the induction phase. AbbVie said it anticipates a regulatory decision later in 2026, though no formal PDUFA date has been disclosed publicly.
The clinical evidence underpinning the submission comes from the AFFIRM trial (NCT06063967), a Phase III, randomized, placebo-controlled, double-blind study evaluating risankizumab administered subcutaneously as an induction treatment in adults with moderately to severely active Crohn's disease. A total of 289 patients were randomized in a 2:1 ratio to receive either risankizumab subcutaneously or placebo. The study enrolled a population that included both biologic-naive patients and those who had previously failed advanced therapies, with 65% of participants having prior advanced therapy failure. Co-primary endpoints were achievement of clinical remission defined by a Crohn's Disease Activity Index score below 150, and endoscopic response, both assessed at week 12. AbbVie described the data as positive, though detailed efficacy figures from AFFIRM have not been published in a peer-reviewed journal based on the information available at the time of the filing announcement.
Crohn's disease affects an estimated one million people in the United States and is characterized by chronic transmural inflammation of the gastrointestinal tract, most frequently at the ileocolonic junction. The condition follows a progressive course and carries risk of bowel stricture, fistula formation, and surgical intervention. The therapeutic landscape has expanded considerably over the past decade, moving from anti-tumor necrosis factor agents such as infliximab and adalimumab toward a broader set of mechanistically distinct biologics and small molecules. Vedolizumab, an anti-integrin agent, and ustekinumab, which inhibits both IL-12 and IL-23, were approved for Crohn's disease in 2014 and 2016 respectively, while the selective IL-23 p19 inhibitor class has emerged more recently as a focus of development activity.
Risankizumab was the first agent in that selective IL-23 p19 inhibitor class to receive US FDA approval for Crohn's disease, in 2022. It functions by binding to the p19 subunit of IL-23, blocking the cytokine without inhibiting IL-12, a distinction from ustekinumab's dual mechanism. Mirikizumab, another IL-23 p19 inhibitor, received FDA approval for Crohn's disease in January 2025, and guselkumab has been under regulatory evaluation in the same indication. The class now occupies a defined position in treatment algorithms, particularly for patients who have experienced inadequate response to anti-TNF therapy, with head-to-head data from the SEQUENCE trial supporting risankizumab's positioning relative to ustekinumab in anti-TNF-experienced patients.