Secukinumab Label Revises Indications and Usage for Psoriasis

The FDA-listed label for COSENTYX (secukinumab) was revised effective August 25, 2026. The recorded change concerned the product’s “Indications and Usage” section and included treatment language for moderate to severe plaque psoriasis.

Background

Secukinumab is identified in the label as a human interleukin-17A antagonist. The supplied label summary states that COSENTYX is indicated for the treatment of moderate to severe plaque psoriasis, abbreviated as PsO, in adults and pediatric patients 6 years and older who are candidates for systemic therapy or p. The supplied text ends at “or p,” so the remaining wording of that indication is not available in the data provided.

What changed

The event was classified as an FDA label revision affecting indications and usage. The available record does not provide a comparison with the prior label, identify whether wording was added, removed, or otherwise changed, or specify any additional indication or population beyond the psoriasis language included in the supplied summary.

The data also do not describe dosing, administration, contraindications, warnings, precautions, clinical-trial results, efficacy measurements, safety findings, or a change to the product’s approval status. Accordingly, the documented event supports reporting a revision to the label’s indications-and-usage section, but not a more specific characterization of the underlying regulatory wording.

What this means

For clinicians and researchers, the key documented point is that the COSENTYX prescribing information carried an indications-and-usage revision effective August 25, 2026. The supplied information places moderate to severe plaque psoriasis in adults and pediatric patients aged 6 years and older within the stated treatment language, for patients who are candidates for systemic therapy or p.

Because the available data do not include the complete revised section or the prior version, the exact practical difference in eligibility or use cannot be determined from this record alone. The full DailyMed label should be consulted to verify the complete indication and any associated wording.

Source

Source: U.S. Food and Drug Administration, DailyMed label document for COSENTYX, reflecting an indication-and-usage revision effective August 25, 2026. The source is hosted at dailymed.nlm.nih.gov.