Dupixent Receives CHMP Endorsement for Pediatric Eosinophilic Esophagitis Treatment in the EU

The Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Dupixent (dupilumab) for the treatment of eosinophilic esophagitis in children as young as one year old within the European Union (EU). The recommendation by CHMP marks a significant step in providing a therapeutic option for young patients suffering from this chronic immune-mediated disease, characterized by inflammation of the esophagus.

Phase 3 Study Backs Dupixent's Efficacy

A pivotal phase 3 study has served as the foundation for the CHMP's recommendation. The study's findings revealed that a significantly greater proportion of children treated with Dupixent achieved histological remission compared to those given a placebo. This outcome underscores Dupixent's potential to ameliorate eosinophilic esophagitis symptoms, thereby improving the quality of life for affected children.

Sanofi's Involvement in Dupixent's Development

Sanofi SNY, a Paris-based healthcare giant with global operations encompassing research, development, manufacturing, and marketing of medical solutions, is instrumental in the development of Dupixent. This recommendation is expected to enhance Sanofi's therapeutic portfolio as it awaits final approval for Dupixent in treating pediatric eosinophilic esophagitis within the EU.

Implications for Regeneron Pharmaceuticals

Regeneron Pharmaceuticals REGN, which has worked in collaboration with Sanofi, may also experience a positive impact on its operations following the CHMP's endorsement. The approval of Dupixent is anticipated to strengthen Regeneron's market position, bringing a novel treatment option to a younger demographic across Europe.

Dupixent, CHMP, Sanofi, REGN, SNY, EosinophilicEsophagitis, Pediatric