Thursday, the FDA approved Regeneron Pharmaceutical Inc REGN / Sanofi SA’s SNY Dupixent (dupilumab) for the treatment of pediatric patients aged 1 to 11 years, weighing at least 15 kg, with eosinophilic esophagitis (EoE).
EoE is a recognized chronic allergic/immune condition of the esophagus. It is a disease in which eosinophils (a type of white blood cell) build up in the esophagus.
EoE may experience heartburn, vomiting, abdominal discomfort, trouble swallowing, food refusal, and failure to thrive.
Dupixent is now the first and only medicine approved in the U.S. specifically indicated to treat these patients.
Also Read: Sanofi/Regeneron’s Blockbuster Prescription Drug Dupixent Shows Additional Promise In Chronic Lung Disorder.
This approval expands the initial FDA approval for EoE in May 2022 for patients aged 12 years and older, weighing at least 40 kg.
The FDA evaluated Dupixent for this expanded indication under Priority Review.
Approximately 21,000 children under the age of 12 in the U.S. are currently being treated for EoE with unapproved therapies. However, the actual prevalence of children with the disease is likely higher, given that symptoms can be mistaken for other conditions and there are delays in diagnosis.
Head of Global Development, Immunology and Inflammation at Sanofi said, “Young children with eosinophilic esophagitis have significant unmet medical needs; despite existing treatment options, 40% of these children in the U.S. under the age of 12 continue to experience symptoms of this disease.”
The FDA approval is based on data from the Phase 3 EoE KIDS trial with two parts evaluating the efficacy and safety of Dupixent in children aged 1 to 11 years with EoE.
At 16 weeks, 66% of children who received higher doses of Dupixent at tiered dosing regimens based on weight (n=32) achieved histological disease remission, the primary endpoint, compared to 3% for placebo (n=29).
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.
In addition, a greater decrease in the proportion of days with one or more signs of EoE was observed in children treated with Dupixent at 16 weeks compared to placebo.
Price Action: REGN shares are up 0.14% at $950.19 during the premarket session on the last check Friday. SNY stock is up 0.92% at $50.34.