AbbVie Files for SKYRIZI Subcutaneous Induction in Crohn's Disease

AbbVie has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for SKYRIZI (risankizumab-rzaa) as a subcutaneous (SC) induction therapy for adult patients with moderately to severely active Crohn's disease. The submission is supported by positive data from the Phase 3 AFFIRM study, which evaluated the efficacy and safety of SC induction.

Currently, SKYRIZI is indicated for Crohn's disease using an initial intravenous (IV) induction phase followed by SC maintenance. If approved, this new filing would offer clinicians and patients the flexibility to choose between SC and IV administration for the induction phase, potentially allowing for a fully subcutaneous treatment journey from the start of therapy. Under the proposed dosing regimen, patients who achieve a clinical response during the SC induction phase would continue with the established SC maintenance dose of 360 mg every eight weeks.

The filing aligns with AbbVie's broader strategy to enhance patient convenience and treatment adherence in the competitive inflammatory bowel disease (IBD) market. SKYRIZI and Rinvoq (upadacitinib) — two immunology treatments for psoriasis, inflammatory bowel disease, and rheumatoid arthritis — delivered a combined $25.9 billion in revenue in 2025, more than $8 billion above the prior year, already exceeding AbbVie's own 2027 long-term peak guidance by more than $500 million. In FY2025, SKYRIZI generated $17.56 billion in revenue (+49.9%) and Rinvoq generated $8.3 billion (+39.1%), together more than tripling Humira's $4.54 billion, which fell 49.5% under biosimilar pressure.

AbbVie reported total FY2025 revenue of $61.16 billion. The company guided the combined SKYRIZI and Rinvoq franchise to over $31 billion in 2026, representing more than 20% growth. Consensus estimates project FY2026 revenue of $67.07 billion and normalized EPS of $14.52.

The FDA also approved the all-oral, fixed-duration combination of Venclexta and acalabrutinib for previously untreated chronic lymphocytic leukemia patients, supported by Phase 3 AMPLIFY trial data, expanding Venclexta's addressable market beyond its existing $2.79 billion annual revenue base. Additional regulatory momentum included Rinvoq winning FDA clearance in giant cell arteritis, Emrelis receiving accelerated approval in NSCLC, and a litigation settlement securing Rinvoq against generic competition until at least April 2037.

AbbVie's pipeline presentation at the Piper Sandler Immunology Symposium revealed multiple late-stage readouts expected in 2026, including lutikizumab and Rinvoq week-16 data in hidradenitis suppurativa (HS), SKYRIZI subcutaneous IBD data, and alpha4beta7 combination results. The company is also progressing Phase III programs for lutikizumab in HS, etentamig in multiple myeloma, and the Parkinson's drug tavapadon targeted for U.S. approval in Q3 2026.

The FDA issued a complete response letter for TrenibotE — an experimental short-acting botulinum toxin for facial wrinkles — on manufacturing grounds, though the agency raised no safety or efficacy concerns and management expects to resubmit within months, with a revised approval path extending into 2027. AbbVie also filed a lawsuit against HHS challenging Botox price controls under the Inflation Reduction Act, a case assigned to U.S. District Judge Carl Nichols. Botox contributed just over 10% of the company's FY2025 revenue.