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Sanofi and Regeneron’s Dupixent gets more positive feedback from U.S. FDA: companies

FILE PHOTO: The logo of Sanofi is pictured during the Viva Tech start-up and technology summit in Paris, France, May 25, 2018. REUTERS/Charles Platiau/File Photo

PARIS (NewsHeaders) – The U.S. Food & Drug Administration (FDA) regulator gave more positive feedback on the Dupixent eczema treatment being developed by drugmakers Sanofi and Regeneron, the companies said on Tuesday.

The two firms said the FDA had accepted for a priority Review the supplemental Biologics License Application for Dupixent in adolescents aged 12 to 17 with moderate-to-severe atopic dermatitis whose disease was inadequately controlled with “topical therapies” or for whom such treatment was medically inadvisable.

Dupixent was launched in the United States in April 2017 for the treatment of moderate-to-severe eczema in adults, and the product is seen as a key sales driver for both Sanofi and Regeneron.

Reporting by Sudip Kar-Gupta; editing by Richard Pullin

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