FDA Agrees to Review Regeneron's Dupixent for Use by Younger Children

The Food and Drug Administration (FDA) has accepted an application from Sanofi (NASDAQ: SNY) and Regeneron Pharmaceutical (NASDAQ: REGN) to review the drug Dupixent for use by children ages 6 to 11 with moderate-to-severe atopic dermatitis (aka, eczema). If approved, Dupixent will become the first biologic medication approved by the FDA for use by this age group.

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Sanofi and Regeneron already market Dupixent in the U.S. for use by moderate-to-severe eczema patients ages 12 and up. A human monoclonal antibody that targets the interleukin-4 (IL-4) and interleukin-13 (IL-13) proteins, Dupixent is a top-selling treatment that had annualized sales exceeding $2.5 billion as of the end of the third quarter of 2019.

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Source Fool.com