FDA approves efficacy supplement for AbbVie's Skyrizi

The U.S. Food and Drug Administration approved a supplemental Biologics License Application for Skyrizi (risankizumab-rzaa), sponsored by AbbVie Inc, with a submission status date of 2026-10-23. The filing was submission number 53 under application BLA761105, classified as an efficacy supplement and reviewed under priority status, with a status of approved.¹

The FDA record lists two Skyrizi injectable products covered under the approval. One formulation is listed at a strength of 150MG/ML and the other at 75MG/0.83ML, both administered by injection.¹

The database entry does not specify the particular indication, patient population, or clinical trial data associated with this efficacy supplement. Skyrizi, marketed by AbbVie, has an established regulatory history under BLA761105, and this latest supplemental approval adds to that record as of the October 23, 2026 status date. No additional details on dosing regimen changes, label updates, or the clinical rationale behind the submission were included in the available FDA documentation.

Readers seeking the specific clinical or labeling changes tied to this approval should consult AbbVie's own disclosures or the FDA's detailed review documents, as the Drugs@FDA database entry reviewed here provides only the administrative status of the submission rather than the substantive content of the approved supplement.