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

 Sanofi and Regeneron’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

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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