The Food and Drug Administration (FDA) has accepted an application from Sanofi (SNY -1.57%) and Regeneron Pharmaceutical (REGN -0.60%) 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.
The FDA will review Dupixent under an accelerated timeline, which should result in a decision in six months. Approval would allow Sanofi and Regeneron to market Dupixent as an add-on therapy in patients who are responding inadequately to alternative treatments, such as topical corticosteroids.
In phase 3 trials, combining Dupixent with topical corticosteroids improved skin-clearing versus topical corticosteroids alone in 6- to 11-year-olds. Specifically, one-third of patients taking Dupixent every four weeks achieved clear or almost clear skin compared to just 11% of patients taking a placebo. Itching, anxiety, depression, and other factors also significantly improved for patients taking Dupixent.
Trials are ongoing that may clear the way for its use by even younger children someday. A study of Dupixent in pediatric eczema patients ages 6 months to 5 years is underway with results anticipated in a couple of years.
