Pharmaceutical company Johnson & Johnson (J&J) (NYSE:JNJ) announced on Thursday that the US Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) to include evidence in the TREMFYA (guselkumab) label for the inhibition of progression of structural joint damage in adults with active psoriatic arthritis (PsA).

J&J said that inclusion of this key outcome reflects that TREMFYA is the only IL-23 inhibitor proven to help stop further structural damage, offering patients with active PsA a first-line treatment option that provides effective symptom control and no new safety signals, while significantly inhibiting irreversible joint damage.

The label update is supported by 24-week results from the Phase 3b APEX study. The study met its primary endpoint of reducing joint symptoms (ACR20) and its major secondary endpoint of inhibiting progression of structural damage, as measured by change in the PsA-modified van der Heijde-Sharp (vdH-S) score, compared to placebo in bio-naive patients.

Additionally, for patients in the study's placebo group who switched to TREMFYA at Week 24, the rate of radiographic progression was reduced by 57% from Week 24 through Week 48, demonstrating benefit even after initial disease progression. Data from the APEX study were consistent with the well-established safety profile of TREMFYA, with no new safety signals identified.

TREMFYA is approved in Europe, Canada, Japan, and a number of other countries for the treatment of adults with moderate to severe plaque psoriasis and for the treatment of adults with active psoriatic arthritis. The legal manufacturer for TREMFYA is Janssen Biotech Inc.