Shots:

• The approval was based on P-III trial (PRIME) & (PRIME2) evaluating Dupixent vs PBO with/out topical treatments in 151 & 160 patients with uncontrolled PN
• In both trials, 44% & 37% vs 16% & 22% experienced a reduction in itch @12wks. while an improvement was increased @24wks. where 60% & 58% vs 18% & 20% experienced a reduction in itch from baseline, clear or almost clear skin (48% & 45% vs 18% & 16%) @24wks., improved health-related QoL while reducing measures of skin pain & symptoms of anxiety/depression from baseline
• The safety results were consistent with the known safety profile of Dupixent in its approved indications. The product received an additional 1yr. marketing protection in the EU, following CHMP recommendation

Ref: Globenewswire | Image: Sanofi