FDA approves Regeneron, Sanofi's Dupixent in babies, young children for eczema
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Regeneron Pharmaceuticals (NASDAQ:REGN) and Sanofi (NASDAQ:SNY) on Tuesday said the U.S. FDA had approved their medicine Dupixent for children aged 6 months to 5 years with inflammation of the skin.
The indication is specifically for children aged 6 months to 5 years with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

"Moderate-to-severe atopic dermatitis in babies and young children is more than just a rash â the intense itch can make them scratch uncontrollably throughout the day and night and cause their skin to crack and bleed," said Julie Block, CEO at National Eczema Association.
The FDA approval was based on a phase 3 trial which met its main goal and its secondary endpoints.
REGN and SNY said that regulatory filings for this age group is also underway by the European Union's drug regulator and authorities in other countries.
REGN stock and U.S.-listed shares of SNY both down marginally after hours.