By Stephen Nakrosis 

Regeneron Pharmaceuticals Inc. and Sanofi said Tuesday the U.S. Food and Drug Administration approved Dupixent to treat certain children with atopic dermatitis.

The companies said the FDA approved Dupixent, or dupilumab, for children 6 to 11 years old with moderate-to-severe atopic dermatitis whose disease isn't adequately controlled with topical prescription therapies or when those therapies aren't advisable.

The companies said Dupixent is the only biologic medicine approved for this population.

Atopic dermatitis is a form of eczema which usually develops in early childhood.

The companies said the FDA approval was based on a the results of a Phase 3 trial which studied Dupixent combined with topical corticosteroids compared to TCS alone. Children with severe atopic dermatitis who were treated with Dupixent and TCS experienced significant improvements in overall disease severity, skin clearance and itch, the companies said.

The FDA previously granted breakthrough therapy designation to Dupixent for the treatment of severe atopic dermatitis in children 6 months to 11 years not well controlled on topical prescription medications.


Write to Stephen Nakrosis at


(END) Dow Jones Newswires

May 26, 2020 12:10 ET (16:10 GMT)

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