Regeneron’s Dupixent (dupilumab) Receives EC’s Approval as First Targeted Medicine for Severe Atopic Dermatitis
- The EC has approved Dupixent for sev. AD in children aged 6mos. to 5yrs. The approval was based on the P-III trial evaluating Dupixent (200/300mg, q4w) + low-potency TCS vs TCS alone in 162 children aged 6mos. to 5yrs.
- The results showed that 46% vs 7% of patients achieved ≥75% improvement in overall disease severity, 14% vs 2% achieved clear or almost clear skin & 55% vs 10% reduction in overall disease severity from baseline & 42% vs 1% reduction in itch from baseline
- Improvement in sleep quality, skin pain, and health-related QoL were seen in an overall and sev. populations while long-term efficacy data showed the clinical benefit at 16wks. sustained through 52wks. The safety results were consistent with the known safety profile of Dupixent
Ref: GlobeNewswire | Image: Regeneron
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