Guselkumab gets FDA Nod for X-ray Protection Save

The U.S. Food and Drug Administration (FDA) has approved Johnson & Johnsons supplemental Biologics License (sBLA) to include evidence in the guselkumab (Tremfya) label for the inhibition of progression of structural joint damage in adults with active psoriatic arthritis (PsA). 

Guselkumab is an IL-23 inhibitor indicated for use in psoriasis, psoriatic arthritis, ulcerative colitis and Crohns disease.  The inhibition of structural damage in PsA was proven in the APEX study, a 24-week Phase 3b study. The study showed a significant ACR20 response (primary endpoints, with inhibiting progression of structural damage, as a secondary endpoint when compared to placebo in bio-naïve patients.