Johnson & Johnson (JNJ), a pharmaceuticals company, on Friday announced FDA approval of a label expansion for TREMFYA in treating joint damage associated with psoriatic arthritis.
Psoriatic arthritis (PsA) is a chronic, immune-mediated, inflammatory joint disease that leads to peripheral joint inflammation, enthesitis, dactylitis, axial disease and skin lesions.
TREMFYA (guselkumab) is a fully-human, dual-acting, monoclonal antibody that received FDA approval in 2017 for the treatment of plaque psoriasis, psoriatic arthritis, ulceratice colitis, and Crohn's disease. The drug acts by inhibiting IL-23, and binding to CD-64 to neutralize inflammation at the cellular source.
The approval of the supplemental Biologics License Application (sBLA) comes after positive data reported from the Phase 3b APEX multicenter, randomized, double-blind, placebo-controlled trial.
The study met its primary endpoint over the 24-week treatment period, marking reduced ACR20 scores for joint pain. Additionally, radiographic progression decreased by 57% from week 24 to week 48 showing benefits after initial disease progression.
JNJ closed Thursday at $230.80, down 0.21%. In the pre-market, shares are trading at $231.07, up 0.10%.
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