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# Dupixent Wins FDA Expanded Indication
- URL: https://www.fdaweb.com/dupixent-wins-fda-expanded-indication/
- Published: 2024-01-25T12:00:00.000Z
- Updated: 2026-09-14T14:21:16.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156214

FDA has approved an expanded indication for Regeneron Pharmaceuticals and Sanofi’s Dupixent (dupilumab) for treating pediatric patients aged one to 11 years with eosinophilic esophagitis (EoE). The approval expands the initial 5/2022 approval for EoE in patients aged 12 years and older.

“EoE is a chronic, progressive disease associated with type 2 inflammation that is thought to be responsible for damaging the esophagus and impairing its function,” the companies say. “EoE can severely impact a child’s ability to eat, and they may experience heartburn, vomiting, abdominal discomfort, trouble swallowing, food refusal and failure to thrive.”

Approval was based on data from the Phase 3 EoE KIDS trial with two parts ([Part A](https://www.globenewswire.com/Tracker?data=Nycme1USTytUWkvWeHB4j4%5FAkZiI9F6-TZjgPOmUh3QfiCRs2b8wqWLbqthxgf4LV0gxVXnsY8AJz0XH9CokYnarFARgQMJsWpRrMwhsnaQggvwqMKhRJnj7tdCmzMW6b3Fhx0-Uiy6CIRr0wojpS%5FCmLUJM2OlIsuM58vibL5OX%5FYKe3JpVW-TQUCOKPbnigv6sP06kcbCmS5rcyhQVOg==&ref=fdaweb.com) and [Part B](https://www.globenewswire.com/Tracker?data=Nycme1USTytUWkvWeHB4j%5FzzrB8zfWlfW0UPlfqCSy6cQTjT7nZO-VQG-rc0-ms7ONDEoYJh-GHX3J4jP3HsWZVxO2vmR%5FUOoAHp%5Fwqx27x3k7vO8pNbRVhtOxM-pq5j8Peau9PFLiw-VKl0SoMAC7UaRdRx9RtABzFSGvWoN%5FpLs1cmZsF61aoORlQVCib9VRmJL0brK2k8t%5FkpS2mpvA==&ref=fdaweb.com)) evaluating the therapy’s efficacy and safety in children aged one to 11 years with EoE, according to the companies. “At 16 weeks, 66% of children who received higher dose Dupixent at tiered dosing regimens based on weight (n=32) achieved histological disease remission (≤6 eosinophils/high power field), the primary endpoint, compared to 3% for placebo (n=29),” they say. “Histological remission was sustained at week 52, with 17 of 32 (53%) children treated with Dupixent in Parts A and B. Histological remission was also achieved at week (52 in 8 of 15 (53%) children who switched to Dupixent from placebo in Part B.”

Monoclonal antibody Dupixent works by inhibiting the signaling of the IL-4 and IL-13 pathways, the companies say. It’s currently approved for treating atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, and prurigo nodularis.