Benzinga | Aug 30, 2021 06:59AM EDT

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 (NASDAQ:SNY) and Regeneron Pharmaceuticals Inc (NASDAQ: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.