AbbVie Seeks FDA OK for SKYRIZI SC Induction, Confronts $18B Franchise Threat
AbbVie filed an FDA application for subcutaneous induction of SKYRIZI in adults with moderately to severely active Crohn’s disease, supported by positive Phase 3 AFFIRM data and targeting approval later this year. A small biotech competitor has rattled AbbVie’s $18 billion immunology franchise with a potentially disruptive therapy.
1. FDA Application for SKYRIZI Subcutaneous Induction
AbbVie submitted a Biologics License Application to the FDA for subcutaneous induction dosing of SKYRIZI (risankizumab-rzaa) in adults with moderately to severely active Crohn’s disease. This submission is backed by positive Phase 3 AFFIRM trial data showing clinical remission (CDAI <150) and endoscopic response at week 12 in 289 randomized patients, including 65% with prior advanced therapy failure. The company expects FDA approval later in 2026, enabling patients to choose between intravenous and subcutaneous induction before transitioning to maintenance dosing every eight weeks.
2. Small Biotech Challenges AbbVie’s $18 Billion Immunology Franchise
A smaller biotechnology firm has introduced a novel therapy targeting the same inflammatory pathways as SKYRIZI, generating investor concern over potential market share loss for AbbVie’s $18 billion immunology franchise. Details on the competitor’s clinical data are limited, but analysts warn that early market traction could pressure AbbVie’s growth forecasts in Crohn’s disease and related indications.