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.
© 2025 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Posted-In: atopic dermatitis Briefs Phase 3 ResultsBiotech News Health Care General