The Food and Drug Administration (FDA) has approved Dupixent® (dupilumab) for the treatment of eosinophilic esophagitis (EoE) in patients 12 years of age and older weighing at least 40kg.
The approval was based on efficacy and safety data from a randomized, double-blind, placebo-controlled phase 3 trial (ClinicalTrials.gov Identifier: NCT03633617), which included two 24-week treatment periods (Parts A and B). Eligible patients had ≥15 intraepithelial eosinophils per high-power field (eos/hpf) following treatment with a proton pump inhibitor either prior to or during the screening period and symptoms of dysphagia.
In both parts, patients were randomly assigned to receive Dupixent 300mg subcutaneously once weekly or placebo. The coprimary endpoints were histological remission (defined as peak esophageal intraepithelial eosinophil count of ≤6 eos/hpf), and the absolute change in Dysphagia Questionnaire (DSQ) score, at 24 weeks.
In Part A, 59.5% (n=25/42) of patients in the Dupixent arm achieved histological remission at week 24 vs 5.1% (n=2/39) in the placebo arm (treatment difference, 57%; 95% CI, 40.9-73.1). Patients in the Dupixent arm experienced a 21.92 point improvement in disease symptoms, as measured by the DSQ score, vs a 9.60 point improvement for placebo.
In Part B, 58.8% (n=47/80) of patients in the Dupixent arm achieved histological remission vs 6.3% (n=5/79) in the placebo arm (treatment difference, 53.5%; 95% CI, 41.2-65.8). Patients in the Dupixent arm experienced a 23.8 point improvement in disease symptoms, as measured by the DSQ score, vs a 13.90 point improvement for placebo.
The safety profile of Dupixent for EoE was generally consistent with its known profile for its other approved indications. The most common adverse reactions were injection site reactions, upper respiratory tract infections, joint pain, and herpes viral infections.
“Dupixent is the first and only medicine specifically indicated to treat eosinophilic esophagitis in the United States, and today’s approval marks the fourth disease for which Dupixent is now indicated, reinforcing the promise of targeting IL-4 and IL-13 to effectively treat diseases with underlying type 2 inflammation,” said George D. Yancopoulos, MD, PhD, President and CSO at Regeneron, and a principal inventor of Dupixent.
Dupixent is also approved for the treatment of atopic dermatitis, asthma and chronic rhinosinusitis with nasal polyps.
- FDA approves first treatment for eosinophilic esophagitis, a chronic immune disorder. News release. US Food and Drug Administration. Accessed May 20, 2022. https://www.prnewswire.com/news-releases/fda-approves-first-treatment-for-eosinophilic-esophagitis-a-chronic-immune-disorder-301552266.html
- FDA approves Dupixent® (dupilumab) as first treatment for adults and children aged 12 and older with eosinophilic esophagitis. News release. Regeneron Pharmaceuticals, Inc. Accessed May 20, 2022. https://www.prnewswire.com/news-releases/fda-approves-dupixent-dupilumab-as-first-treatment-for-adults-and-children-aged-12-and-older-with-eosinophilic-esophagitis-301552282.html
- Dupixent. Package insert. Sanofi and Regeneron; 2022. Accessed May 20, 2022. https://www.regeneron.com/downloads/dupixent_fpi.pdf