Dupilumab receives FDA's Breakthrough Therapy Status for eosinophilic esophagitis
USA: Dupilumab (Dupixent) has received the US FDA's Breakthrough Therapy designation for the treatment of eosinophilic esophagitis (EoE) in patients aged 12 years and older. Breakthrough Therapy designation is designed to expedite the development and review of drugs in the U.S. that target serious or life-threatening conditions.
The designation for this investigational use is based on positive results from Part A of a Phase 3 trial that evaluated Dupixent in patients 12 years and older with EoE. Part A of the randomized, double-blind, placebo-controlled trial of 81 patients met both of its co-primary endpoints, as well as all key secondary endpoints.
Other key findings of the trial include:
- Patients treated weekly with Dupixent 300 mg over a 24-week treatment period experienced a reduction in symptoms, esophageal inflammation and abnormal endoscopic findings in the esophagus.
- The trial demonstrated safety results consistent with the known safety profile of Dupixent in its approved indications.
The EoE trial is ongoing, with additional patients enrolling in Part B as well as patients continuing in a 28-week extended active treatment period (Part C) after completing either Part A or Part B.
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