Sanofi's Dupixent Receives FDA Priority Review for Eosinophilic Esophagitis in Children Aged 1–11

Sep 26, 2023 16:31 CST Updated 16:31

Sanofi

Pharmaceutical R&D Developer

On September 26, Sanofi announced that the FDA has accepted the priority review of the supplemental Biologics License Application (sBLA) for Dupixent® to treat children aged 1-11 with eosinophilic esophagitis (EoE). The FDA’s target action date is January 31, 2024.

Dupixent® is the first and only therapy approved in the U.S. for the treatment of children and adults aged 12 years and older, weighing at least 40kg, with eosinophilic esophagitis.

This sBLA is based on data from the Phase III EoE KIDS trial (Part A and Part B), which evaluated the efficacy and safety of Dupixent in children aged 1-11 with EoE.

In Part A, compared with placebo, the proportion of patients who achieved histologic disease remission (defined as peak intraepithelial eosinophil count in the esophagus ≤6 eosinophils [eos]/hpf) at Week 16 using a weight-based dosing regimen reached the primary endpoint.

Part B is the active treatment extension period, during which Dupixent was evaluated over 36 weeks. The results showed that Dupixent maintained histological remission (a secondary endpoint) over 52 weeks. Dupixent also increased body weight across all age percentiles, which was an exploratory endpoint in Part A and a secondary endpoint in Part B.

The more common (≥5%) adverse reactions of Dupixent are COVID-19, rash, headache, viral gastroenteritis, diarrhea, and nausea. These are generally consistent with the known safety profile for the previous indication of irritable bowel syndrome.

Dupixent is a fully human monoclonal antibody that inhibits signaling in the IL-4 and IL-13 pathways. It has been approved for use in atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), nodular prurigo, and otitis media.

In the first half of 2023In the annual report, Dupixent's sales reached 4.9 billion euros, increasing by 36.7% year-on-year, and it is expected to break into the 10-billion-dollar club this year. In March, its COPD indication succeeded in phase III trials, potentially becoming the first biologic to enter the COPD market, driving further sales growth.

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