FDA Approves Dupixent for Some Children With Atopic Dermatitis
27 May 2020 - 2:25AM
Dow Jones News
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 stephen.nakrosis@wsj.com
(END) Dow Jones Newswires
May 26, 2020 12:10 ET (16:10 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
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