FDA Grants Priority Review to Dupilumab sBLA for Eosinophilic Esophagitis

The US Food and Drug Administration today accepted for priority review a supplemental Biologics License Application (sBLA) for dupilumab (Dupixent) to treat eosinophilic esophagitis (EoE) in adult and pediatric patients aged ≥12 years.

The announcement, made by codevelopers Sanofi and Regeneron, says the target action date for the FDA decision on dupilumab’s investigational use is August 2, 2022.

There are currently no approved treatments in the US to treat the underlying pathophysiology of the chronic, progressive type 2 inflammatory disease. Of the approximately 160 000 persons living with EoE in the US, estimates are that likely 48 000 of them have failed multiple treatments, according to the companies’ statement.

Dupixent 300 mg weekly is the only biologic medicine to show positive, clinically meaningful phase 3 results in adults and adolescents with EoE.

Dupilumab was granted Orphan Drug status by the FDA in 2017 for the potential treatment of EoE followed in 2020 by a designation as Breakthrough Therapy. The current sBLA is supported by 2 phase 3 clinical trials evaluating the safety and efficacy of dupilumab 300 mg weekly to treat EoE in patients aged ≥12 years and by data from an active long-term extension trial.

Data from one of the phase 3 clinical trials were reported at the February 2022 American Academy of Allergy, Asthma and Immunology (AAAAI) conference and showed dupilumab significantly improved EoE symptoms vs placebo at week 24. Among the patients in the treatment arm, 64% achieved reduction in disease symptoms vs 41% in the control arm. Patients receiving dupilumab also had significantly greater improvement vs those on placebo on a dysphagia symptom questionnaire. Further, histologic remission was reached by nearly 10 times as many patients receiving dupilumab (59%) vs those in the control group (6%).

Safety results from both phase 3 trials were consistent with the drug’s known safety profile in its approved indications; injection site reactions were the most common adverse event observed, according to the statement.

Dupilumab is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant.