FDA Approves Subcutaneous Induction Regimen for AbbVie's SKYRIZI for Crohn's Disease

The FDA has approved a subcutaneous induction regimen for AbbVie's SKYRIZI for Crohn's disease, allowing patients to start treatment at home with an on-body injector and receive maintenance doses every eight weeks. This label expansion is based on positive results from the AFFIRM study, which achieved its co-primary endpoints at week 12. The approval is anticipated to improve patient convenience and may boost the adoption of SKYRIZI within AbbVie's immunology portfolio.