SANOFI 
The
This new authorisation by the
"With this approval, Dupixent becomes the first and only treatment option for EoE patients aged one year and older, weighing at least 15kg”
"With this approval, Dupixent becomes the first and only treatment option for EoE patients aged one year and older, weighing at least 15kg. By targeting the underlying type 2 inflammation that contributes to this disease, Dupixent has the potential to transform the standard of care for these children as it has for adults and adolescents with EoE," Dr
Dupixent
A promising biologic
First medicine approved in EU for eosinophilic esophagitis
What did the data from the Phase III Dupixent study show?
This FDA approval of the biologic treatment is based on data from the two-part Phase III EoE KIDS trial (Part A and Part B) evaluating the efficacy and safety of Dupixent in children aged one to 11 years with EoE.
According to
- At 16 weeks, 66 percent of children who received higher dose Dupixent at tiered dosing regimens based on weight achieved histological disease remission (≤6 eosinophils/high power field), compared to three percent for placebo
- Histological remission was sustained at week 52, with 17 of 32 (53 percent) children treated with Dupixent in Parts A and B
- Histological remission was also achieved at week 52 in 8 of 15 (53 percent) children who switched to Dupixent from placebo in Part B.
Eosinophilic esophagitis - addressing an unmet need
"… despite existing treatment options, 40 percent of [children with eosinophilic esophagitis] in the US under the age of 12 continue to experience symptoms of this disease," stated Dr
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