AbbVie has filed a regulatory application with the U.S. Food and Drug Administration for a new subcutaneous induction regimen of its drug SKYRIZI® (risankizumab‑rzaa) for adults with moderately to severely active Crohn’s disease. The filing follows positive data from the Phase 3 AFFIRM study, which demonstrated that subcutaneous risankizumab met its co‑primary endpoints of clinical remission and endoscopic response at week 12 in a predominantly treatment‑refractory population.
SKYRIZI is already approved for plaque psoriasis, psoriatic arthritis, Crohn’s disease (via intravenous induction) and ulcerative colitis. The AFFIRM study, which enrolled 65% of patients who had failed advanced therapies, provided the evidence that a simple subcutaneous injection can replace the infusion‑center visits required for the current induction protocol. The new dosing strategy could improve patient convenience and broaden the drug’s market reach in the inflammatory bowel disease space.
The filing is a material development for AbbVie’s immunology franchise, which generated $8.626 billion in net revenues in Q4 2025, up 18.3% from the prior year. SKYRIZI alone contributed $5.006 billion in Q4 2025 net revenues, a 32.5% increase, and accounted for a large share of the $61.160 billion total company revenue, up 8.6% year‑over‑year. The addition of a subcutaneous induction option is expected to further strengthen SKYRIZI’s revenue trajectory and reinforce AbbVie’s position as a leading biologic provider in Crohn’s disease.
Management emphasized the strategic importance of the filing. Kori Wallace, vice president and global head of immunology clinical development, said, “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 move aligns with AbbVie’s broader strategy to expand the therapeutic footprint of its key growth drivers and to capture additional market share in the competitive biologic landscape for inflammatory bowel disease.
While the filing itself does not trigger an immediate market reaction, the announcement signals AbbVie’s confidence in the long‑term growth of its immunology portfolio and its commitment to improving patient access to its therapies. The new subcutaneous induction option is expected to enhance patient adherence, reduce infusion‑center burden, and potentially increase market penetration in the Crohn’s disease segment.
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