FDA approves efficacy supplement for Sun Pharma's Ilumya

The U.S. Food and Drug Administration approved a supplemental application for Ilumya (tildrakizumab-asmn), sponsored by Sun Pharma Global, with a submission status date of October 29, 2026. The approval covers Ilumya, an injectable product with the active ingredient tildrakizumab-asmn at a strength of 100MG/1ML.¹

The agency recorded this as submission number 31 under application number BLA761067. The submission was classified as an efficacy supplement and given standard review priority, with a submission status of "AP," indicating approval.¹

An updated product label was filed in connection with this action. The label document is dated October 30, 2026.¹

The FDA's drug approval database does not specify the particular indication, patient population, or clinical trial data associated with this efficacy supplement beyond noting its classification and approval status. Readers seeking the specific nature of the labeling or efficacy change should consult the newly filed label document directly, as the agency record provided here does not detail the content of the supplement beyond its administrative classification.