Shots:
- FDA has approved Tremfya (SC; Wk. 0, 4 & then Q8W) for children (≥6yrs.; ≥40kg) with mod. to sev. plaque PsO, who are candidates for systemic therapy or phototherapy, or active PsA; an FDA application was also filed to add joint damage inhibition in active PsA adults to Tremfya’s label
- Plaque PsO approval was based on P-III (PROTOSTAR) trial in pediatric pts, which met its co-1EPs of PASI 90 (~56% vs 16%) & IGA 0/1 (66% vs 16%) at 16wks.; ~40% vs 4% achieved IGA 0 at 16wks., plus supportive data from the P-III (VOYAGE 1 & 2) studies in adults
- PsA approval was based on PK extrapolation from Tremfya PsO/PsA studies, incl. VOYAGE 1 & 2, DISCOVER 1 & 2 as well as PROTOSTAR, supporting that efficacy & safety shown in adults & pediatric PsO pts extend to children with active PsA
Ref: Johnson & Johnson | Image: Johnson & Johnson | Press Release
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