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

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: StraitTimes