for active psoriatic arthritis — prevention of further joint damage
FDA approved a supplemental BLA expanding Tremfya's label to include prevention of further joint damage in adults with active psoriatic arthritis, based on data showing slowed structural damage progression. Cements Tremfya as the only IL-23 inhibitor with this specific labelling claim.
Psoriatic arthritis is a chronic inflammatory joint disease that can lead to permanent structural damage. Tremfya is an antibody that blocks a key inflammatory signal called interleukin-23. By calming this specific part of the immune system, Tremfya may help prevent the progressive joint damage associated with the condition.
The purpose of this study is to evaluate long-term safety of subcutaneous guselkumab in pediatric participants with moderately to severely active ulcerative colitis, or moderately to severely active Crohn's disease, or juvenile psoriatic arthritis (jPsA).
Source: ClinicalTrials.gov