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

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

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

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

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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