[News Brief] FDA Approves Tremfya Label Expansion for Psoriatic Arthritis

FDA Approves Tremfya Label Expansion for Psoriatic Arthritis

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.


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