Sanofi’s Dupixent (dupilumab) Receives the US FDA’s Approval as First Biologic for Children Aged 6-11 Years with Moderate-to-Severe Atopic Dermatitis

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The FDA approval is based on P-III study assessing Dupixent + TCS vs TCS as monothx. in children with severe AD. In the trial, children treated with Dupixent and TCS experienced improvements in overall disease severity, skin clearance and itch
Results @16wks.: Dupixent (q4w & q2w) improvement in average EASI patients receiving (84% vs 49% & 80% vs 48%); EASI-75 ( 75% vs 28% & 75% vs 26%); 4-point reduction in itch intensity on a 0-10-point scale (54% vs 12% & 61% vs 13%); clear or almost clear skin (30% vs 13% & 39% vs 10%) respectively
Dupixent is a mAb targeting the signaling of IL-4 and IL-13 proteins, being evaluated in 8,000+ patients aged 6yrs. and older across 40+ clinical studies. The companies are helping people receiving Dupixent via DUPIXENT MyWay program

Click here to read full press release/ article | Ref: Sanofi | Image: PRWeek