Blog Big Molecule Watch April 13, 2022

FDA Accepts Regeneron and Sanofi’s DUPIXENT (Dupilumab) sBLA for Priority Review

Last week, Regeneron Pharmaceuticals, Inc. and Sanofi announced that the FDA has accepted a Priority Review of the supplemental Biologics License Application (sBLA) for DUPIXENT (dupilumab) 300 mg weekly to treat patients aged 12 years and older with eosinophilic esophagitis (EoE).  EoE is a chronic, immune-mediated, atopic inflammatory condition of the esophagus.  According to the announcement, the target action date for the FDA decision on this investigational use is August 3, 2022.

In 2017, DUPIXENT was granted Orphan Drug designation for the potential treatment of EoE.  And in September 2020, the FDA granted Breakthrough Therapy designation to Dupixent for the treatment of patients aged 12 years and older with EoE.  Regeneron reported that the sBLA is supported by data from two Phase 3 trials evaluating the efficacy and safety of Dupixent 300 mg weekly in patients aged 12 years and older with EoE and data from an active long-term extension trial.  According to Regeneron, if it is approved, DUPIXENT would be the first medicine available in the U.S. indicated to treat EOE.

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