EMA Approves Dupixent for Young EoE Patients

The European Medicines Agency (EMA) has granted approval for Sanofi and Regeneron’s drug Dupixent (dupilumab) for the treatment of eosinophilic esophagitis (EoE) in children aged one to 11 years. This regulatory decision extends the use of Dupixent to a younger pediatric population who weighs at least 15 kilograms and have not responded adequately to conventional medicinal therapies.

Initially approved for adolescents and adults in the European Union in January 2023, Dupixent is now the first and only medication available for young children with EoE, with approvals also established in Canada and the United States. The EMA’s expanded approval is a significant step forward, offering a new treatment option for younger patients who previously had no approved medications specifically targeting their condition.

The decision by the EMA was influenced by the positive results from the EoE KIDS clinical trial, a two-part, randomized, double-blind, placebo-controlled Phase III study. This trial evidenced the efficacy and safety of Dupixent in treating pediatric patients with EoE. The safety outcomes of this trial were consistent with the established safety profile of Dupixent in older patients.

Houman Ashrafian, the head of research and development and executive vice-president at Sanofi, emphasized the importance of this approval. He noted that up to half of all children in the European Union suffering from EoE remain uncontrolled despite existing standard treatments. These young patients often face severe symptoms such as vomiting and difficulty swallowing, making it challenging for them to maintain a healthy weight. Ashrafian highlighted that this new approval provides a crucial treatment option for pediatric patients who previously had no specific medication approved for their condition.

The EoE KIDS study involved 71 children in its first part, who were administered a weight-based dosing regimen of Dupixent. After 16 weeks, 68% of these participants achieved the primary endpoint of histological disease remission, while only 3% of those in the placebo group reached this milestone. These positive results were sustained for up to one year in the second part of the study. Additionally, a 108-week open-label extension period, designated as Part C, was recently concluded to evaluate longer-term outcomes.

Dupixent, developed using Regeneron’s VelocImmune technology, is a fully human monoclonal antibody. It functions by inhibiting the signaling pathways of interleukin-4 (IL4) and interleukin-13 (IL13), which are critical in the pathophysiology of eosinophilic esophagitis. The medication is being co-developed by Regeneron and Sanofi under a global collaboration agreement.

Moreover, Sanofi has recently forged a partnership with Orano Med aimed at advancing the development of radioligand therapies for the treatment of rare cancers. This collaboration signifies Sanofi’s ongoing commitment to expanding its therapeutic portfolio and addressing unmet medical needs across various disease areas.

The EMA's recent approval for Dupixent represents a noteworthy advancement in the treatment of EoE, particularly for younger patients who have limited treatment options. This new indication is expected to provide substantial relief and improve the quality of life for many children suffering from this debilitating condition.