Skyrizi FDA Application for Crohn's SC Induction
Key Questions
What is AbbVie's recent FDA submission for Skyrizi in Crohn's disease?
AbbVie submitted a supplemental New Drug Application (sNDA) to the FDA for Skyrizi (risankizumab) as a subcutaneous induction therapy in adults with moderately to severely active Crohn's disease. This expands on the existing intravenous induction option.
What data supports the sNDA for subcutaneous Skyrizi in Crohn's disease?
The Phase 3 AFFIRM study met its primary and key secondary endpoints, demonstrating efficacy of subcutaneous Skyrizi induction. This filing is based on data from this trial.
When is FDA approval expected for Skyrizi subcutaneous induction in Crohn's, and why is it significant?
Approval is anticipated in late 2026. It bolsters AbbVie's immunology portfolio growth toward a $30 billion-plus peak, helping offset Humira patent losses.
AbbVie submits sNDA to FDA for Skyrizi (risankizumab) subcutaneous induction in adults with moderate-severe Crohn's Disease; Phase 3 AFFIRM met endpoints, expands from IV option. Approval eyed late 2026; bolsters immunology growth to $30B+ peak offsetting Humira.