First-Ever Therapy Approved: Dupixent (dupilumab) Gains FDA Nod for Eosinophilic Esophagitis in Adults and Adolescents

On May 21, the U.S. FDA announced the approval of Dupixent (dupilumab), a重磅 IL-4/IL-13 inhibitor jointly developed by Sanofi and Regeneron, for an expanded indication to treat eosinophilic esophagitis (EoE) in adults and pediatric patients aged 12 years and older (weighing at least 40 kg). The press release noted that this is the first FDA-approved therapy for the treatment of EoE.

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. Sometimes, even swallowing small amounts of food or sipping water can cause pain and esophageal blockage. In severe cases, a feeding tube is the only way 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 the 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. Less than two months ago, the FDA granted it Priority Review for the supplemental Biologics License Application for the treatment of eosinophilic esophagitis.

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

FDA Approval Based on Results of Phase 3 Trial Composed of Two Parts (A and B). The trial results showed that, in patients receiving Dupixent treatment, disease symptoms decreased by 69% and 64% from baseline in parts A and B respectively after 24 weeks of treatment. The corresponding figures for the placebo group were 32% and 41%.

The number of patients in the Dupixent treatment group who achieved histological disease remission was approximately 10 times that of the placebo group.

In terms of safety, the safety profile of Dupixent is similar to that of the approved indications. The most common adverse events are injection site reactions, upper respiratory tract infections, arthralgia, and herpesvirus infections.

"Regular meals throughout the day are essential, but difficulty swallowing food is a common symptom for patients with eosinophilic esophagitis. This often causes them to worry about pain and esophageal blockage at every meal of the day. Our Phase 3 clinical development program shows that using Dupixent weekly can improve swallowing ability and reduce inflammation in the esophagus. This milestone approval represents a new treatment option for patients and their caregivers."

References:

[1] FDA Approves First Treatment for Eosinophilic Esophagitis, a Chronic Immune Disorder. Retrieved May 20, 2022, from https://www.prnewswire.com/news-releases/fda-approves-first-treatment-for-eosinophilic-esophagitis-a-chronic-immune-disorder-301552266.html

[2] Press Release: FDA approves Dupixent® (dupilumab) as first treatment for adults and children aged 12 and older with eosinophilic esophagitis. Retrieved May 20, 2022, from https://www.globenewswire.com/news-release/2022/05/20/2447906/0/en/Press-Release-FDA-approves-Dupixent-dupilumab-as-first-treatment-for-adults-and-children-aged-12-and-older-with-eosinophilic-esophagitis.html

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