Dupixent recommended for EU approval by the CHMP to treat eosinophilic esophagitis in children as young as 1 year old
September 20, 2024 – Clinical Trials, Drug Discovery, Pharmaceutical – CHMP, EMA, Regeneron, Sanofi, approvals, eosinophilic esophagitis
- Recommendation based on a phase 3 study showing a significantly greater proportion of children on Dupixent achieved histological remission, compared to placebo, consistent with improvements seen in adults and adolescents
- If approved, Dupixent would be the first and only medicine in the EU indicated for EoE in this age group.
20 September 2024 — New York, US — The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the expanded approval of Dupixent (dupilumab) in the European Union (EU) for eosinophilic esophagitis (EoE) in children down to 1 year of age. The recommendation is for children aged 1 to 11 years who weigh at least 15 kg and who are inadequately controlled by, intolerant to, or who are not candidates for conventional medicinal therapy. The European Commission is expected to announce a final decision in the coming months. Dupixent is already approved in the EU for certain adults and adolescents aged 12 years and older with EoE.
The positive CHMP opinion is supported by a two-part (Part A and B) EoE KIDS phase 3 study in children aged one to 11 years. In Part A, a significantly greater proportion of children receiving weight-based doses of Dupixent achieved histological disease remission at week 16, compared to placebo, with results sustained for up to one year in Part B. At week 16, caregivers of children treated with Dupixent also observed improvements in the frequency and severity of EoE signs, and fewer days with at least one sign of EoE, compared to placebo. These data established a bridge showing the response to Dupixent in children with EoE is similar to that of the approved adult and adolescent EoE populations.
The safety results in the EoE KIDS study were generally consistent with the known safety profile of Dupixent in adolescents and adults with EoE. AEs more commonly observed with Dupixent (≥10%) in either weight-based dosing regimen compared to placebo during Part A were COVID-19, nausea, injection site pain and headache. The long-term safety profile of Dupixent evaluated in Part B was similar to that observed during Part A.
Results from the study were recently published in The New England Journal of Medicine. The use of Dupixent in children aged one to 11 years with EoE is investigational in the EU and is not yet approved.
About Regeneron
Regeneron is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases. Regeneron pushes the boundaries of scientific discovery and accelerates drug development using our proprietary technologies, such as VelociSuite®, which produces optimized fully human antibodies and new classes of bispecific antibodies. We are shaping the next frontier of medicine with data-powered insights from the Regeneron Genetics Center® and pioneering genetic medicine platforms, enabling us to identify innovative targets and complementary approaches to potentially treat or cure diseases. For more information, please visit www.Regeneron.com
About Sanofi
We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people’s lives. Our team, across the world, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Visit: www.sanofi.com.
