Shots:
- The EC has approved Tremfya (SC) for children (≥6yrs.) with mod. to sev. PsO, who are candidates for systemic therapy
- Approval was based on P-III (PROTOSTAR) trial in 120 pediatric pts, which met its co-1EPs of PASI 75 (~76% vs 20%) & IGA 0/1 (66% vs 16%) at 16wks., with ~40% vs 4% achieving IGA 0 at 16wks., plus supportive PK data from the P-III (VOYAGE 1 & 2) studies in adults
- Guselkumab is a fully human, dual-acting IL-23p19 inhibitor that blocks IL-23 signaling while binding CD64 on IL-23–producing cells to enhance targeted immune modulation
Ref: Globenewswire | Image: J&J |Press Release
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