Eosinophilic esophagitis medicine approval expanded

The US Food and Drug Administration (FDA) has approved Dupixent ^® (dupilumab) as a treatment for children patients aged one to 11 years, weighing at least 15kg with eosinophilic esophagitis (EoE).

This new authorisation by the FDA’s expands its initial approval for EoE in May 2022 for patients aged 12 years and older, weighing at least 40kg.

“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 George Yancopoulos, PhD, Board co-chair, President and Chief Scientific Officer at Regeneron shared.

Dupixent

A promising biologic

Sanofi and Regeneron Pharmaceuticals highlighted that as a non-immunosuppressant, the fully human monoclonal antibody inhibits signalling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways.

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 Regeneron Pharmaceuticals and Sanofi:

• 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

Dr Yancopoulos explained that the disease is “debilitating and progressive” and threatens a patient’s basic ability to eat.

“… 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 Naimish Patel, Head of Global Development, Immunology and Inflammation at Sanofi.