Johnson & Johnson files with US FDA to include new evidence in Tremfya (guselkumab) label as the only IL-23 inhibitor to demonstrate significant inhibition of joint structural damage in active psoriatic arthritis

Johnson & Johnson

29 July 2025 - Submission is supported by 24 week results from the Phase 3b APEX study in adults with active psoriatic arthritis treated with Tremfya, the only dual acting IL-23 inhibitor.

Johnson & Johnson today announced the submission of a supplemental biologics license application to the US FDA seeking approval to include new evidence in the Tremfya (guselkumab) label for the inhibition of progression of structural damage in adults with active psoriatic arthritis.

Read Johnson & Johnson press release

Michael Wonder

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Michael Wonder

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Medicine , US , Dossier , Registration