Johnson & Johnson (JNJ) announced on Friday that the FDA has approved a label expansion for TREMFYA, authorizing its use in treating joint damage associated with psoriatic arthritis.
Psoriatic arthritis (PsA) is a chronic inflammatory joint disease mediated by the immune system. It typically manifests as peripheral joint inflammation, dactylitis, enthesitis, axial disease, and various skin lesions.
TREMFYA (guselkumab) is a dual-acting, fully-human monoclonal antibody. Initially approved by the FDA in 2017, it is used to treat Crohn’s disease, ulcerative colitis, psoriatic arthritis, and plaque psoriasis. The medication functions by inhibiting IL-23 and binding to CD-64 to neutralize inflammation at the cellular level.
This supplemental Biologics License Application (sBLA) approval follows positive results from the Phase 3b APEX trial, a randomized, double-blind, placebo-controlled multicenter study.
The trial successfully met its primary endpoint over a 24-week period, demonstrating a reduction in ACR20 scores for joint pain. Furthermore, radiographic progression decreased by 57% between week 24 and week 48, indicating significant therapeutic benefits following initial disease progression.
