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

 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

Sanofi and Regeneron Receive the FDA’s Priority Review Acceptance for Dupixent’s sBLA to Treat Moderate-to-Severe Atopic Dermatitis 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

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

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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