Dupixent Becomes First Biologic To Show Benefit In Infant Patients With Atopic Dermatitis

A Phase 3 trial evaluating Dupixent (dupilumab) for treating children aged 6 months to 5 years with moderate-to-severe atopic dermatitis met its primary and secondary endpoints.
Sanofi SA SNY and Regeneron Pharmaceuticals Inc REGN are jointly developing dupilumab for many diseases.
The data showed Dupixent, when added to standard of care topical corticosteroids (TCS), significantly reduced overall disease severity and improved skin clearance, itch, and health-related quality of life measures at 16 weeks compared to TCS alone.
Dupixent is the first biologic medicine to show positive results in this young population.
It remains the only approved biologic medicine in patients 6 years and older with uncontrolled moderate-to-severe atopic dermatitis.
During the 16-week treatment period, Dupixent patients were 50% less likely to experience a skin infection (12% Dupixent, 24% placebo), and the total number of infections was nearly 70% lower (11 Dupixent, 34 placebo).
28% achieved clear or almost clear skin compared to 4% with placebo, the primary endpoint.
53% achieved 75% or greater overall disease improvement from baseline compared to 11% with placebo, the co-primary endpoint outside of the U.S.
The trial demonstrated similar safety results to the known safety profile of Dupixent in atopic dermatitis.
Price Action: REGN stock closed 0.37% lower at $663.29 on Friday, while SNY stock is up 0.31% at $51.99 during the premarket session on Monday's last check.