FDA approves supplement 13 for Cosentyx, Novartis's secukinumab
The efficacy supplement for the 150mg injectable was approved on October 15, 2026, according to FDA records.
The FDA approved a supplemental application for Cosentyx (secukinumab) on October 15, 2026. The approval covers an injectable formulation of secukinumab at 150MG strength, administered by injection.1
The sponsor listed in the FDA record is NOVARTIS PHARMS CORP.1
The submission, numbered 13, was classified by the agency as an efficacy supplement. The review was conducted under standard priority, and the submission status shows as approved (AP) with a status date of 2026-10-15.1
The application number associated with this approval is BLA761349.1 The FDA's approval letter for this action, dated October 16, 2026, is listed in the agency's records under the application numbers 761349Orig1s013 and 125504Orig1s099.
No further details on the specific indication or clinical data supporting this supplemental approval were included in the available FDA record.
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