J&J Secures FDA Approval for TREMFYA, First IL-23 Inhibiting Joint Damage

Johnson & Johnson received FDA approval for a supplemental Biologics License Application for TREMFYA® (guselkumab). The expanded label includes the drug's ability to inhibit structural joint damage in adults with active psoriatic arthritis.

TREMFYA® is now the only IL-23 inhibitor with proven capability to prevent structural damage progression. This approval strengthens the drug's competitive position within the immunology market.

The FDA based its decision on a study that met its primary endpoint of reducing joint symptoms. The study also achieved its major secondary endpoint by inhibiting structural damage compared to a placebo.