NEW BRUNSWICK (dpa-AFX) - Johnson & Johnson (JNJ) Tuesday said it has submitted supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) to include new evidence in the TREMFYA label for the inhibition of progression of structural damage in adults with active psoriatic arthritis (PsA).
The submission is supported by the Phase 3b APEX study in patients with active PsA, which met its primary endpoint of reducing joint symptoms and major secondary endpoint of inhibited progression of structural damage.
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