FDA Accepts Dupixent for Priority Review for Patients with Eosinophilic Esophagitis

FDA has accepted the supplemental biologics license application for Priority Review for Dupixent to treat patients 12 years and older with eosinophilic esophagitis (EoE), a chronic and progressive disease that damages the esophagus and impairs the ability to swallow. The target action date for the FDA decision is August 3, 2022.

According to the press release, there are approximately 160,000 patients in the United States living with eosinophilic esophagitis who are currently treated, with 48,000 of them having failed multiple treatments. Dupixent was granted Orphan Drug designation by FDA for the potential treatment of EoE in 2017 as well as Breakthrough Therapy designation in September 2020. Priority review is granted to therapies that have the potential to provide significant improvements in the treatment, diagnosis, or prevention of serious conditions.

Individuals with EoE struggle with swallowing, making even small amounts of food painful to swallow and a choking hazard. The disease can cause narrowing of the esophagus, causing the need for dilation of the esophagus, which is often painful. Many individuals rely on a feeding tube as the only option to ensure proper caloric intake and adequate nutrition. Individuals with EoE may experience a poor quality of life and have a greater chance of developing anxiety and depression than those without the disease, according to Sanofi. If approved, Dupixent would be the first medicine available in the US indicated to treat EoE.