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Sanofi & Regeneron Reports the US FDA’s Acceptance of sBLA for Priority Review of Dupixent (dupilumab) for Eosinophilic Esophagitis

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Sanofi & Regeneron Reports the US FDA’s Acceptance of sBLA for Priority Review of Dupixent (dupilumab) for Eosinophilic Esophagitis

Shots:

  • The sBLA was based on the 2 P-III trials evaluating the efficacy & safety of Dupixent (300mg, qw) vs PBO in patients aged ≥12yrs. with EoE along with the results from a long-term extension trial. The US FDA’s decision is expected on Aug 3, 2022
  • The results showed that the patients achieved an improvement in the signs & symptoms  @24wks. including the ability to swallow & a reduction in eosinophil count. The safety results were consistent with the known safety profile of Dupixent in its approved indications
  • If approved, Dupixent will be 1st treatment in the US for EoE. The therapy has received the BTD from the US FDA for the same indication in Sept 2020 & ODD in 2017

Ref: Sanofi | Image: Sanofi

Click here to­ read the full press release 

Neha

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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