FDA accepts supplemental biologics license application for Dupixent for EoE
Regeneron Pharmaceuticals Inc. and Sanofi announced that the FDA accepted for priority review a supplemental biologics license application for Dupixent 300 mg for adults and children aged 12 years and older with eosinophilic esophagitis.
“This news is very welcome and encouraging, as there are no FDA-approved medicines for eosinophilic esophagitis, and there is a large unmet need,” Evan S. Dellon, MD, MPH, professor in the department of medicine, division of gastroenterology and hepatology at The University of North Carolina School of Medicine and co-principal investigator of the pivotal trials, told Healio. “EoE is a chronic and progressive inflammatory disease that causes esophageal injury and remodeling. This ultimately places a high burden on patients, for whom swallowing food can be difficult, painful, and worrisome. If approved, dupilumab would be the first medicine indicated for the treatment of EoE in the United States and has the potential to reduce the underlying inflammation and help improve patients’ ability to swallow.”
According to a release from the biotechnology companies, the application was supported by two phase 3 trials that assessed the efficacy and safety of 300 mg weekly Dupixent (dupilumab; Sanofi Genzyme, Regeneron) in patients aged 12 years and older with EoE, as well as data from an active long-term extension trial.
Compared with placebo, dupilumab at 24 weeks significantly improved signs and symptoms of EoE, including ability to swallow and eosinophil counts in the esophagus. Safety results in these trials were similar to the safety profile of dupilumab in its already approved indications, with injection site reactions being the most common adverse event observed.
According to the release, the FDA granted breakthrough therapy designation for dupilumab in September 2020; the target action date for FDA decision on this investigational use is Aug. 3, 2022. Regulatory filings are also being planned globally in 2022.
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