Johnson & Johnson expands FDA filing for tremfya label in psoriatic arthritis

Johnson & Johnson submitted a supplemental Biologics License Application, or sBLA, to the FDA, seeking approval to include new evidence in the tremfya label for the inhibition of progression of structural damage in adults with active psoriatic arthritis, or PsA. The submission is supported by the Phase 3b APEX study in patients with active PsA, which achieved both its primary endpoint of reducing joint symptoms and its major secondary endpoint of inhibited progression of structural damage vs. placebo in bio-naive patients. Data from the APEX study were consistent with the safety profile of tremfya.