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Tagged With "Dupilumab"

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Dupixent® Shows Positive Results in Phase 3 of Trial for Ages 6 to 11 With Severe Atopic Dermatitis

AAFA Community Services ·
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that a pivotal Phase 3 trial evaluating Dupixent® (dupilumab) to treat severe atopic dermatitis in children aged 6 to 11 years met its primary and secondary endpoints. Dupixent is the first and only biologic to show positive results in this pediatric atopic dermatitis population.
Blog Post

FDA Approves Dupixent® for Moderate-to-Severe Atopic Dermatitis in Adolescents

AAFA Community Services ·
Regeneron Pharmaceuticals, Inc. and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has approved Dupixent® (dupilumab) for adolescent patients 12 to 17 years of age with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Dupixent can be used with or without topical corticosteroids.
Blog Post

FDA Considers Biologic Dupilumab for Children Ages 6 to 11 Years With Moderate-to-Severe Atopic Dermatitis

AAFA Community Services ·
Regeneron Pharmaceuticals, Inc. and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) as an add-on maintenance treatment for children aged 6 to 11 years with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.
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