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Regeneron And Sanofi: Dupixent Granted FDA Breakthrough Therapy Designation For EoE

Regeneron Pharmaceuticals Inc. (REGN) and Sanofi (SNY) announced Monday that Dupixent (dupilumab) has received Breakthrough Therapy designation from the U.S. Food and Drug Administration.

The designation is for the treatment of patients 12 years and older with eosinophilic esophagitis or EoE. The decision is based on positive results from Part A of a Phase 3 trial in patients with EoE.

The companies noted that there are currently no FDA-approved medicines for EoE, a chronic and progressive type 2 inflammatory disease that damages the esophagus and prevents it from working properly.

Dupixent is the first and only biologic to show positive and clinically-meaningful Phase 3 results in patients 12 years and older with EoE.

Regeneron and Sanofi previously reported positive results from Part A of the pivotal Phase 3 trial evaluating Dupixent in patients with EoE.

Part A of the trial of 81 patients met both of its co-primary endpoints, as well as all key secondary endpoints.

The FDA's Breakthrough Therapy designation is designed to expedite the development and review of drugs in the U.S. that target serious or life-threatening conditions.

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