Dupixent Receives FDA Priority Review for First-Ever Treatment of Eosinophilic Esophagitis in Patients Aged 12 and Older

Recently, Regeneron and Sanofi jointly announced that the U.S. FDA has granted priority review status to the supplemental Biologics License Application (sBLA) for Dupixent (dupilumab), a重磅 IL-4/IL-13 inhibitor, for the treatment of eosinophilic esophagitis in patients aged 12 and above. The press release noted that if approved, Dupixent will become the first drug approved in the United States for the treatment of eosinophilic esophagitis.

Eosinophilic Esophagitis: A Chronic, Progressive Type 2 Inflammatory DiseaseEosinophilic esophagitis is a chronic, progressive type 2 inflammatory disease that damages the esophagus, preventing it from functioning properly. At times, even swallowing small amounts of food or sipping water can cause pain and esophageal blockage. In severe cases, a feeding tube is the only means to maintain normal energy intake and weight gain. Patients with eosinophilic esophagitis often experience poor quality of life and are more prone to depression.

Dupixent is a fully human monoclonal antibody that inhibits signaling of the IL-4 and IL-13 proteins. Data from Dupixent clinical trials show that IL-4 and IL-13 are key drivers of type 2 inflammation, which plays a significant role in inflammatory diseases such as asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), and atopic dermatitis. Dupixent has received Breakthrough Therapy designation from the FDA for the treatment of eosinophilic esophagitis.

▲Mechanism of Action of Dupixent (Image Source: Sanofi Official Website)

This sBLA is supported by data from two Phase 3 clinical trials and a long-term extension study. After 24 weeks of treatment with Dupixent, there was a significant improvement in the symptoms of eosinophilic esophagitis compared to placebo, including swallowing ability and the number of eosinophils in the esophagus. In terms of safety, the results of this clinical trial are consistent with the safety profile demonstrated by Dupixent in its already approved indications.

The two companies plan to file regulatory applications worldwide in 2022 to expand the use of Dupixent.

References:

[1] FDA Accepts Dupixent® (dupilumab) for Priority Review in Patients Aged 12 Years and Older with Eosinophilic Esophagitis. Retrieved April 4, 2022, from https://www.prnewswire.com/news-releases/fda-accepts-dupixent-dupilumab-for-priority-review-in-patients-aged-12-years-and-older-with-eosinophilic-esophagitis-301516398.

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