Sanofi’s Dupixent (dupilumab) has secured FDA approval as the first and only medication in the U.S. available for the treatment of eosinophilic esophagitis (EoE) in pediatric patients aged 1 to 11 years.
The approval, following a priority review, expands the initial FDA pediatric nod for EoE in 2022 for patients aged 12 years and older. Dupixent, a jointly developed drug by Regeneron and Sanofi, has climbed to blockbuster status since its FDA approval in 2017, expanding its indications to include asthma, EoEs, and broader eczema patient groups, with sales reaching $8.9 billion last year.
Positive results from the phase 3 EoE KIDS trial demonstrated a higher proportion of children taking Dupixent achieved histological remission compared to those on a placebo. EoE is a chronic condition that damages the esophagus, impacting a child's ability to eat and causing symptoms such as heartburn, vomiting and abdominal discomfort.
Last November, French financial prosecutors conducted a preliminary inquiry into Sanofi regarding potential price manipulation surrounding the launch of Dupixent. The probe focused on possible market manipulation caused by Sanofi's financial communication during the drug's launch.