Regeneron (REGN) Announces Release of Positive Data on Dupixent in 6-Month-Old Children
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Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that The Lancet has published positive results from a Phase 3 Dupixent® (dupilumab) trial in children aged 6 months to 5 years with uncontrolled moderate to severe atopic dermatitis. This data served as the basis for the US Food and Drug Administration (FDA). approval from Dupixent in June 2022 and for regulatory submission under review by the European Medicines Agency.
“The Lancet the publication of these Phase 3 results speaks to the importance of the data showing that dupilumab can alleviate the multidimensional burden that moderate to severe atopic dermatitis places on infants, toddlers and their families,” said Amy S Paller, MD, Walter J Hamlin Professor and Chair of Dermatology and Professor of Pediatrics at Northwestern University Feinberg School of Medicine, and principal investigator of the trial. “By addressing the key inflammatory pathway behind atopic dermatitis, the trial demonstrated that dupilumab not only treated debilitating symptoms like persistent itching and skin lesions, but also significantly improved sleep and reduced pain – two aspects of daily life that are essential to the development and well-being of any child.
Data from this trial showed that adding Dupixent to low potency topical corticosteroids (TCS) significantly improved skin clearance and reduced overall disease severity and itch compared to TCS alone (placebo) at 16 weeks. . Additionally, Dupixent patients saw significant improvement in measures of sleep quality and skin pain, as well as patient or caregiver-reported outcomes and health-related quality of life. A significantly lower proportion of patients on Dupixent required rescue medication, compared to those on placebo.
Safety results over 16 weeks were similar to the safety profile in patients 6 years of age and older with atopic dermatitis. The most frequently observed adverse events with Dupixent (≥5%) included conjunctivitis (5% Dupixent, 0% placebo), herpes viral infections (6% Dupixent, 5% placebo), molluscum contagiosum (5% Dupixent, 3 % placebo), rhinorrhea (5% Dupixent, 1% placebo) and dental caries (5% Dupixent, 0% placebo).
The safety and effectiveness of Dupixent in children 6 months to 5 years of age with uncontrolled atopic dermatitis has not been fully evaluated by any regulatory authority outside of the United States.