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FDA approves label extension for guselkumab in active PsA
On May 28, 2026, the U.S. Food and Drug Administration (FDA) approved a supplemental biologics application (sBLA) for a guselkumab label extension to include evidence for the inhibition of structural joint damage progression in adults with active psoriatic arthritis (PsA).1
This label update was supported by the 24-week results from the phase IIIb APEX study (NCT04882098), in which guselkumab met the primary endpoint of 20% improvement in American College of Rheumatology (ACR20) joint symptoms and the major secondary endpoint of inhibiting the progression of structural damage compared with placebo in biologic-naïve patients with active PsA.1
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