Regeneron, Sanofi: FDA Accepts Dupixent Priority Review In Children With Atopic Dermatitis

Regeneron Pharmaceuticals, Inc. (REGN), and French drug maker Sanofi (SNYNF,SNY) announced Thursday that the U.S. Food and Drug Administration has accepted Dupixent (dupilumab) for Priority Review in children aged 6 months to 5 years with moderate-to-severe atopic dermatitis.

The supplemental Biologics License Application or sBLA has been accepted for Dupixent as an add-on maintenance treatment for children aged 6 months to 5 years with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

The target action date for the FDA decision on this investigational use is June 9, 2022. Dupixent remains the only biologic medicine approved for patients 6 years of age and older in this indication.

Atopic dermatitis is a chronic type 2 inflammatory skin disease, and 85 to 90% of patients develop symptoms (onset of disease) before 5 years of age, which can often continue through adulthood.

If approved, Dupixent will be the first biologic medicine available in the U.S. to treat uncontrolled moderate-to-severe atopic dermatitis for these young children.

The sBLA is supported by data from the pivotal Phase 3 trial evaluating the efficacy and safety of Dupixent added to standard-of-care topical corticosteroids (TCS) in children aged 6 months to 5 years with uncontrolled moderate-to-severe atopic dermatitis.

The trial met all primary and secondary endpoints, showing that Dupixent and TCS significantly improved skin clearance and reduced overall disease severity and itch at 16 weeks compared to TCS alone.

In 2016, the FDA granted Breakthrough Therapy designation for Dupixent for the treatment of severe atopic dermatitis in children aged 6 months to 11 years.

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