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.
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.