
The U.S. Food and Drug Administration (FDA) has approved Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) and Sanofi’s (NASDAQ:SNY) lead drug candidate Dupixent® (dupilumab) 300 mg weekly for patients with eosinophilic esophagitis (EoE) aged 12 years and older.
This regulatory approval is based on clinical data from a Phase 3 trial with two parts evaluating the efficacy and safety of Dupixent 300 mg weekly, compared to placebo, in patients aged 12 years and older with EoE.