Sanofi’s Dupixent (dupilumab) Receives the US FDA’s Approval for the Treatment of Atopic Dermatitis in Children Aged 6 months to 5 years
Shots:
- The US FDA has approved Dupixent for AD in children aged 6mos. to 5yrs. whose disease is not adequately controlled with topical prescription therapies
- The approval was based on the P-III trial evaluating Dupixent (200/300mg, q4w) with low-potency TCS vs TCS alone in 162 children for 16wks. The trial met the 1EPs & 2EPs i.e., patients achieved clear or almost clear skin (28% vs 4%), ≥75% improvement in overall disease severity from baseline (53% vs 11%), reduction in itch (48% vs 9%)
- The safety profile was similar to the safety profile in patients aged ≥6yrs. & long-term safety profile from 52wks. OLE trial in children aged 6mos. to 5yrs. was similar to the pivotal trial & consistent with those observed in older patients
Ref: Sanofi | Image: Sanofi
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