Sanofi and Regeneron Receive the US FDA’s Priority Review Acceptance for Dupixent’s sBLA to Treat Moderate-to-Severe Atopic Dermatitis in Children Aged 6 to 11 Years

Shots:

• The US FDA has accepted PR for Dupixent’s (dupilumab) sBLA as an add-on maintenance therapy for children aged 6-11yrs. with mod. to sev. AD not well controlled on topical prescription therapies
• The sBLA is based on data that includes P-III study assessing Dupixent + TCS vs TCS as monothx. in children with severe AD that demonstrated improvement in overall disease severity, skin clearing, itching and health-related QoL
• Dupixent is mAb targeting IL-4 & IL-13, developed utilizing Regeneron’s VelocImmune technology and has received the US FDA’s BT designation for the AD in children aged 6mos.-11yrs. not well controlled on topical prescription medications. The anticipated PDUFA date for this sBLA, in children aged 6-11yrs. is 26 May, 2020. If approved, Dupixent would be the first biologic available in the US for these children

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