Johnson & Johnson has announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) to include new evidence in the label of TREMFYA® (guselkumab) for adults with active psoriatic arthritis. This submission is based on 24-week results from the Phase 3b APEX study, which demonstrated significant inhibition of joint structural damage, making TREMFYA® the only IL-23 inhibitor to provide such benefits. The study achieved its primary and major secondary endpoints, showcasing TREMFYA®'s effectiveness in symptom control and joint damage inhibition in bio-naïve patients. The data from this study align with TREMFYA®'s well-established safety profile, and further information will be shared at upcoming medical meetings.
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