The U.S. Food and Drug Administration (FDA) approved a supplemental application for Skyrizi (risankizumab-rzaa) on March 6, 2026. This approval, identified as BLA 761105 S-42, specifically pertains to the drug's efficacy and was submitted by sponsor AbbVie Inc.
Background
Risankizumab, marketed under the brand name Skyrizi, is a therapeutic agent developed by AbbVie Inc. The FDA's action represents a supplemental approval, which typically expands upon an existing indication or modifies aspects of the drug's approved use based on new efficacy data.
What this means
The FDA's decision to grant a supplemental efficacy approval for Skyrizi (risankizumab-rzaa) signifies that new clinical data has supported an expansion or refinement of the drug's demonstrated effectiveness. This provides updated guidance for healthcare professionals regarding the appropriate use and patient populations that may benefit from risankizumab-rzaa therapy.
Source
This information is based on data from the U.S. Food and Drug Administration (FDA). The supplemental approval for Biologics License Application (BLA 761105 S-42) for Skyrizi (risankizumab-rzaa) was recorded on March 6, 2026, and is publicly available on the accessdata.fda.gov website.