Regeneron and Sanofi Report the US FDA’s Acceptance of sBLA for Review of Dupixent to Treat Moderate-to-Severe Asthma in Children

March 4, 2021 Auto Bot Acceptance, Asthma, Dupixent, FDA, Moderate, Receive, regulatory, Review, sBLA, Severe, Treat 0

Shots:

  • The sBLA is based on P-III study assessing Dupixent + SOC maintenance therapy in children aged 6-11yrs. with moderate-to-severe asthma with type 2 inflammation
  • The study resulted in a reduction of severe asthma attacks and rapidly improved lung function within 2wks, safety results were generally consistent with the known safety profile of Dupixent.
  • Dupixent is currently approved as an add-on treatment for patients with uncontrolled moderate-to-severe asthma aged ≥12yrs. The anticipated PDUFA date is Oct 21, 2021, and the EU regulatory submission is planned for Q1’2021

Click here ­to­ read full press release/ article | Ref: Regeneron | Image: Foursquare

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