The European Medicines Agency (EMA) approved Sanofi/Regeneron’s Dupixent (dupilumab) to treat eosinophilic esophagitis (EoE) in children as young as one.
The approval extends the use of Dupixent to patients aged one to 11 who weigh a minimum of 15kg and have not responded well to traditional medicinal therapy.
The EMA’s decision expands on the initial European Union (EU) approval for treating EoE in adolescents and adults, granted in January 2023.
Dupixent is the first and only medication for these young patients, with approvals also in place in Canada and the US.
The EMA’s decision is based on the outcomes of EoE KIDS, a two-part, randomised, double-blind, placebo-controlled Phase III trial that demonstrated Dupixent’s efficacy and safety in children with EoE.
The safety results from the EoE KIDS study were consistent with the known safety profile of Dupixent in adolescents and adults with EoE.
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Sanofi research and development head and executive vice-president Houman Ashrafian stated: “Up to half of all children in the EU with eosinophilic esophagitis remain uncontrolled despite existing standard of care treatment options, and, as a result, many of these young patients struggle to maintain weight due to serious symptoms such as vomiting and difficulty swallowing.
“This milestone provides an important new treatment for paediatric patients who were previously without options specifically approved for their disease.”
Part A of the EoE KIDS study included 71 children who received a weight-based dosing regimen of Dupixent.
After 16 weeks, 68% of these patients achieved the primary endpoint – histological disease remission – compared to just 3% in the placebo group. These outcomes were maintained for up to one year in Part B of the study.
Part C, a 108-week open-label extension period to assess longer-term outcomes, was recently completed.
Developed using Regeneron’s VelocImmune technology, Dupixent is a fully human monoclonal antibody that blocks the interleukin-4 (IL4) and interleukin-13 (IL13) signalling pathways.
Regeneron and Sanofi are co-developing Dupilumab under a global collaboration agreement.
Sanofi also recently partnered with Orano Med to advance the development of radioligand therapies for rare cancers.
