French healthcare company Sanofi S.A. (Euronext Paris:SAN) (Nasdaq:SNY) announced on Wednesday that the European Medicines Agency has approved Dupixent (dupilumab) to treat eosinophilic esophagitis (EoE) in children as young as one year old.
This approval makes Dupixent the first and only medicine indicated for this condition in this age group in the European Union.
EoE is a chronic disease that can significantly impact a child's ability to eat and grow. Dupixent's approval was based on phase 3 data showing significant improvement in histological disease remission and other key measures in children treated with Dupixent compared to placebo.
The safety profile of Dupixent in this young age group was generally consistent with its known safety profile in older populations. Dupixent is administered subcutaneously and is intended for use under the guidance of a healthcare professional.
Dupilumab is being jointly developed by Sanofi and US biotechnology company Regeneron Pharmaceuticals Inc (Nasdaq:REGN) under a global collaboration agreement.
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