Skyrizi (Risankizumab) Receives FDA Supplemental Approval for Efficacy

The U.S. Food and Drug Administration (FDA) granted a supplemental approval for Skyrizi (risankizumab-rzaa) for efficacy on 2025-09-03. This approval, designated BLA 761262 S-11, was for an efficacy supplement.

What this means

This supplemental approval for Skyrizi (risankizumab-rzaa) indicates that the FDA has reviewed additional data related to the drug's efficacy. Such approvals often expand the drug's label, potentially for a new indication, a new patient population, or an updated dosing regimen, based on demonstrated effectiveness. The specific details of this efficacy supplement would be found in the full FDA documentation.

Source

The information regarding this supplemental approval was obtained from the U.S. Food and Drug Administration (FDA). The approval for BLA 761262 S-11 for Skyrizi (risankizumab-rzaa) was posted on 2025-09-03 on accessdata.fda.gov.