Regeneron Receives EMA’s CHMP Positive Opinion Recommending Expanded Approval of Dupixent (dupilumab) for Atopic Dermatitis
- The EMA’s CHMP has adopted a positive opinion recommending expanded approval for Dupixent to treat sev. AD. The EC’s final decision is expected in the coming months
- The opinion was based on the P-III trial results evaluating Dupixent (200/300mg, q4w) added to SoC low-potency TCS vs low-potency TCS alone in 162 children aged 6mos. to 5yrs.
- The trial met all 1EPs & 2EPs i.e., Dupixent + low-potency TCS showed improvement in skin clearance & reduced overall disease severity @16wks., reduction in itch & skin pain along with improved sleep quality & health-related QoL while the Long-term data showed a sustained improvement in the disease measures @~1yr. & the safety results were consistent with the known safety profile of Dupixent
Ref: Globe Newswire | Image: Regeneron
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