The US Food and Drug Administration (FDA) has approved a label expansion for Tremfya (guselkumab) to include evidence for inhibition of progression of structural joint damage in adults with active psoriatic arthritis.
- Label Update: The expanded label includes evidence that Tremfya can inhibit progression of structural joint damage in adults with active psoriatic arthritis.
- Clinical Evidence: The approval is supported by 24-week results from the Phase 3b APEX study, which met its primary endpoint of reducing joint symptoms and its major secondary endpoint of inhibiting structural joint damage compared with placebo.
- Study Findings: Patients who switched from placebo to Tremfya at Week 24 experienced a 57 per cent reduction in radiographic progression from Week 24 through Week 48.
This summary is based on a news article published by BioSpectrum Asia.
Image for illustrative purposes only. Source: Canva.
About Ehub365
For Corporate Clients, ehub365 division delivers critical insights into the ASEAN medical sector, covering investments, new services, and practitioner news.
A member of 365Asia. Our additional group services are Health365, 365Asia, 健康365, 365Sehat, and 365MEC.