Overview

• The FDA granted Tremfya approval in July 2025 based on Phase III GALAXI 2 and 3 trial outcomes published in The Lancet on July 17.
• GALAXI 2 and 3 were 48-week, double-blind, head-to-head studies enrolling 1,048 patients worldwide to compare two guselkumab dosing regimens against placebo and ustekinumab.
• Patients receiving guselkumab achieved significantly higher rates of endoscopic healing and deep remission versus both placebo and ustekinumab.
• Safety findings aligned with Tremfya’s established profile and the therapy demonstrated a corticosteroid-sparing benefit in patients with prior biologic failures.
• By blocking the interleukin-23 pathway, guselkumab represents a novel mechanism in IBD management that could reshape treatment strategies for moderate-to-severe Crohn’s disease.