FDA Approves Dupixent for Eosinophilic Esophagitis

The FDA has approved Dupixent (dupilumab) to treat patients with eosinophilic esophagitis aged 12 years and older. Eosinophilic esophagitis is an inflammatory disease of the esophagus, causing it to narrow and develop abscesses. People with atopic dermatitis, asthma, or food or environmental allergies have a much greater chance of developing the condition. About 160,000 patients are living with eosinophilic esophagitis in the United States and are currently treated with therapies not specifically approved for the disease.

Dupixent, developed by Regeneron Pharmaceuticals and Sanofi, is the first medicine approved in the United States specifically to treat eosinophilic esophagitis.

The FDA approval is based on data from a phase 3 trial with two parts evaluating the efficacy and safety of Dupixent 300 mg weekly, compared with placebo, in patients aged 12 years and older with eosinophilic esophagitis. After 24 weeks, patients treated with Dupixent 300 mg experienced a 21.9- (Part A) and 23.8-point (Part B) clinically meaningful improvement compared with 9.6- and 13.9-point improvement for placebo. About 10 times as many patients achieved histological disease remission compared with placebo.

The safety results were generally consistent with the known safety profile of Dupixent. Pooled adverse events for both parts of the study were more common in those treated with Dupixent, including injection site reactions, upper respiratory tract infections, arthralgia, and herpes viral infections.

Mary Jo Strobel

“We have waited a long time for an FDA-approved treatment option for eosinophilic esophagitis – an underdiagnosed and misunderstood disease of the esophagus that can make it extremely challenging and uncomfortable to eat and swallow,” Mary Jo Strobel, executive director at the American Partnership for Eosinophilic Disorders, said in a press release.

Dupixent is also approved to treat moderate-to-severe atopic dermatitis, eosinophilic or steroid-dependent asthma, chronic rhinosinusitis with nasal polyposis.