Sanofi and Regeneron’s Dupixent Receives European Commission Approval for Moderate-To-Severe Atopic Dermatitis in Adolescents

Sanofi’s Dupixent Receives European Commission Approval for Moderate-To-Severe Atopic Dermatitis in Adolescents

Shots:

  • The EC has extended the marketing authorization of Dupixent (dupilumab) to include adolescents aged 12 to 17yrs. with mod. to sev. AD which is based on P-III LIBERTY AD program evaluating dupixent vs PBO
  • The P-III LIBERTY program results:  75% improvement in disease extent, Skin improvement measured by EASI-75 (42% vs 8%); clear skin (24% vs 2%); improvement in the EASI score (66% vs 24%); improvement in itch (37% vs 5%); improvement in QoL (61% vs 20%);  improvements in disease severity measured by POEM (63% vs 10%)
  • Additionally, Sanofi and Regeneron have announced results of dupixent in P-III pediatric study assessing dupixent + TCS vs TCS in 367 children with AD aged 6-11yrs. with an additional safety study evaluating dupixent (300mg, q4w & 100/200mg, q2w) vs PBO with its expected FDA submission in Q4’19
  • The P-III pediatric study resulted in improvement in overall disease severity, skin clearing, itching and health-related QoL. Efficacy study results: Clear skin (33% & 30% vs 11%); skin improvement (EASI-75) (70% & 60% vs 27%); improvement in EASI score (82% & 78% vs 49%)
  •  Dupixent is a mAb targeting IL-4 & IL-13 and only biologic approved in the EU for adolescent patients with mod. to sev. AD, being developed in collaboration with Regeneron

News 1 & News 2 to­ read full press release/ article | Ref: Sanofi, Sanofi | Image: Stat News