FDA Approves Dupixent for Pediatric Eosinophilic Esophagitis

The US Food and Drug Administration (FDA) have approved Dupixent (dupilumab) for the treatment of pediatric patients 1 to 11 years of age and weighing 15 kg or more with eosinophilic esophagitis (EoE). Dupixent is the first drug approved to treat these patients in the United States. This approval expands on the FDA's initial approval for EoE in May 2022 for patients 12 years of age and older weighing 40 kg. The FDA reviewed Dupixent for a broad indication through First Look, which is given to drugs that are more effective or safer for treating severe conditions.

EoE is a chronic, progressive disease caused by type 2 inflammations that damages the esophagus and impairs its function. EoE can seriously affect a child's ability to eat, causing shortness of breath, vomiting, abdominal pain, difficulty swallowing, loss of appetite, and failure to thrive. These symptoms can negatively affect growth and development. Treatment of EoE should be continued to reduce the risk of complications and disease progression. In the United States, approximately 21,000 children under the age of 12 are being treated by EE with unapproved treatments. However, because symptoms can be confused with other illnesses, diagnosis can be delayed, and children with this condition may be at increased risk of death.

Dr. Naimish Patel, Head of Global Development, Immunology and Inflammation at Sanofi, said: Despite current treatments, 40% of children under the age of 12 in the United States still have symptoms of death. Today's approval demonstrates our commitment to therapy for young patients with unmet needs and patients in the critical age group who experience difficulty eating and maintaining weight for their eating and food development.