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Wednesday, October 20, 2021

FDA Expands OK of Regeneron/Sanofi Dupixent to Children Aged 6 to 11

 Dupixent is the only biologic medicine to improve lung function in children aged 6 to 11 years in a randomized Phase 3 trial, supporting potential as a best-in-class option

Only biologic medicine approved for children with oral corticosteroid-dependent asthma

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has approved Dupixent® (dupilumab) as an add-on maintenance treatment of patients aged 6 to 11 years with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid-dependent asthma.

https://www.prnewswire.com/news-releases/fda-expands-approval-of-dupixent-dupilumab-to-include-children-aged-6-to-11-years-with-moderate-to-severe-asthma-301405141.html

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