Dupixent recommended for EU approval to treat eosinophilic esophagitis in children
Positive Recommendation by CHMP
Paris and Tarrytown, NY, September 20, 2024 –
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the expanded approval of Dupixent (dupilumab) in the European Union (EU) for the treatment of eosinophilic esophagitis (EoE) in children as young as 1 year old. This recommendation is based on a phase 3 study showing that a significantly greater proportion of children treated with Dupixent achieved histological remission compared to those on a placebo. These results are consistent with the improvements seen in adults and adolescents.
If approved, Dupixent would be the first and only medicine in the EU indicated for EoE in children as young as 1 year old. This could be a major breakthrough in the treatment of this condition, which can cause difficulty swallowing, chest pain, and food impaction.
The recommendation by the CHMP is a promising step towards providing young children with a much-needed treatment option for EoE. With Dupixent showing positive results in clinical trials, it offers hope for improved quality of life for children suffering from this condition.
How this will affect me
As a parent of a child with eosinophilic esophagitis, the potential approval of Dupixent for use in children as young as 1 year old is welcome news. This could mean access to a new treatment option that has shown promising results in clinical trials, offering hope for improvement in my child’s symptoms and quality of life.
How this will affect the world
The approval of Dupixent for the treatment of eosinophilic esophagitis in young children could have a significant impact on the medical world. It would be the first and only medicine indicated for this condition in children as young as 1 year old, filling a gap in treatment options and providing hope for improved outcomes for young patients with EoE.
Conclusion
In conclusion, the recommendation for EU approval of Dupixent for the treatment of eosinophilic esophagitis in children as young as 1 year old is an important step towards addressing the needs of young patients with this condition. With positive results from clinical trials, Dupixent offers hope for improved quality of life for children suffering from EoE. If approved, this could be a significant advancement in the treatment of this condition.
