At Sanofi and Regeneron, it’s all about the kids—at least with respect to their recent advancements of anti-inflammatory powerhouse Dupixent.

On Thursday, the FDA signed off on the IL-4 receptor alpha antagonist to treat children between the ages of 1 and 11 who weigh at least 33 pounds with eosinophilic esophagitis (EoE). Dupixent becomes the first treatment in the U.S. for children in this age group with the disorder.

In May of 2022, the FDA greenlit Dupixent as the first treatment for EoE. That nod was limited to patients ages 12 and up who weigh at least 88 pounds.

Dupixent is approved to treat five inflammatory disorders, and the companies have worked to expand use of the treatment to children. In June of 2022, the FDA gave a thumbs up for Dupixent to treat children between the ages of 6 months and five years who have atopic dermatitis (eczema). Sanofi and Regeneron also have scored an approval for children ages 6 to 11 with asthma.

In the case of EoE, the disorder can be particularly challenging for children as they must be careful about everything they eat, particularly foods that are likely to cause inflammation in the esophagus such as milk, eggs and wheat. The disease can impact growth, weight gain and development. It can also lead to food-related anxiety that can persist throughout adulthood.

Approximately 21,000 children in the U.S. under the age of 12 are being treated for EoE with unapproved therapies, the companies said. And about 9,000 of them don’t respond to their current regimens. The actual prevalence of children with the disease is likely higher, given symptoms can be mistaken for other conditions.

“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,” George Yancopoulos, M.D., Ph.D., Regeneron’s chief scientific officer, said in a statement.

The pediatric approval was based on the EoE KIDS phase 3 trial, which showed a greater proportion of children taking Dupixent achieved histological disease remission at Week 16 compared to placebo. Of those taking a higher weekly dose of Dupixent—based on a tiered dosing regimen determined by weight—66% achieved remission, compared to 3% on placebo.

Dupixent’s initial FDA approval in atopic dermatitis came in 2017, followed by initial nods for asthma (2018), rhinosinusitis with nasal polyps (2019) and prurigo nodularis (2022). Two successful phase 3 trials have set Dupixent up for an approval to treat COPD.

Dupixent raked in sales of $8.7 billion in 2022. Annual global sales are expected to hit $20 billion by the end of the decade.

Author: Kevin Dunleavy

Publication: Fierce Pharma

Link: FDA approves Sanofi and Regeneron's Dupixent for kids with EoE (fiercepharma.com)