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.
The FDA evaluated the Dupixent application under Priority Review, granted approval ahead of more than two months from the scheduled action date of August 3, 2022
George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer at Regeneron, commented : “Eosinophilic esophagitis can be debilitating for patients by inflaming and damaging the esophagus and limiting the ability to eat normally. Dupixent is the first and only medicine specifically indicated to treat eosinophilic esophagitis in the United States, and today's approval marks the fourth disease for which Dupixent is now indicated”.
The companies are planning for submissions to regulatory authorities in other countries by the end of 2022, while a regulatory filing is already under review by the European Medicines Agency for EoE.
With this approval, Dupixent is the first and only medicine indicated to treat eosinophilic esophagitis in the United States.
Regeneron Pharmaceuticals is trading high at $661.14 and Sanofi is trading high 2.5 percent at $54.40
