The U.S. Food and Drug Administration (FDA) approved a supplemental application for Skyrizi (risankizumab-rzaa) for efficacy on September 3, 2025. This approval, designated as BLA 761105 S-39 and sponsored by AbbVie Inc., specifically addresses additional efficacy data for the therapeutic agent.
This supplemental approval for Skyrizi (risankizumab-rzaa) indicates that the FDA has reviewed and accepted additional data supporting the drug's effectiveness. Such approvals are significant as they can lead to an expansion of the drug's label, potentially allowing healthcare providers to prescribe risankizumab for a broader range of patients or specific aspects of conditions where its efficacy has now been further demonstrated. This reflects an ongoing process of evaluating and validating the therapeutic benefits of risankizumab.
The information regarding this supplemental approval was sourced from the U.S. Food and Drug Administration (FDA) on September 3, 2025. Details are publicly available on the accessdata.fda.gov website under application number BLA 761105.