By Cecilia Butini

Sanofi SA said late Tuesday that the U.S. Food and Drug Administration has approved its blockbuster drug Dupixent for use in children aged 6 months to 5 years with moderate-to-severe atopic dermatitis.

The French pharma company said the approval is directed at those children whose disease isn't adequately controlled with topical prescription therapies, or medicines that are applied directly on the skin.

Sanofi also said that a regulatory filing for this age group is under review by the European Medicines Agency, and that submissions to regulatory authorities in other countries are underway.

Write to Cecilia Butini at cecilia.butini@wsj.com

(END) Dow Jones Newswires

June 08, 2022 01:49 ET (05:49 GMT)

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