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Dupixent® (dupilumab) Approved in the European Union as the First and Only Medicine for Young Children with Eosinophilic Esophagitis
Last regeneron pharmaceuticals, inc. earnings: 2/6 06:30 am
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US:NASDAQ Investor Relations: investor.regeneron.com
Approval based on Phase 3 data showing significantly more children aged 1 to 11 years on Dupixent achieved histological disease remission at 16 weeks compared to placebo, which was sustained up to one year Dupixent is the first-ever medicine in the EU indicated to treat these young patients, who persistently struggle to eat at a critical stage in life where growth is crucial TARRYTOWN, N.Y. and PARIS, Nov. 06, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the European Commission (EC) has approved Dupixent® (dupilumab) to treat eosinophilic esophagitis (EoE) in children as young as 1 year of age. Specifically, the approval covers children aged 1 to 11 years who weigh at least 15 kg and who are inadequately controlled by, intolerant to, or who are not candidates for conventional medicinal therapy. This expands the initial approval in the European Union (EU) for EoE in adults and adolescents and makes Dupixent the first and on
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