cover image: Dupixent® (Dupilumab) Recommended for Eu Approval by the CHMP to Treat Eosinophilic Esophagitis (Eoe) in Children as Young as 1 Year Old

Dupixent® (Dupilumab) Recommended for Eu Approval by the CHMP to Treat Eosinophilic Esophagitis (Eoe) in Children as Young as 1 Year Old

2024

The use of Dupixent in children aged 1 to 11 years with EoE is investigational in the EU and is not yet approved. [...] In addition to the currently approved indications, Regeneron and Sanofi are studying dupilumab in a broad range of diseases driven by type 2 inflammation or other allergic processes in Phase 3 trials, including chronic pruritus of unknown origin and bullous pemphigoid. [...] INDICATIONSDUPIXENT is a prescription medicine used: to treat adults and children 6 months of age and older with moderate-to-severe eczema (atopic dermatitis or AD) that is not well controlled with prescription therapies used on the skin (topical), or who cannot use topical therapies. DUPIXENT can be used with or without topical corticosteroids. It is not known if DUPIXENT is safe and effective in [...] with other asthma medicines for the maintenance treatment of moderate-to-severe eosinophilic or oral steroid dependent asthma in adults and children 6 years of age and older whose asthma is not controlled with their current asthma medicines. DUPIXENT helps prevent severe asthma attacks (exacerbations) and can improve your breathing. [...] DUPIXENT is not used to treat sudden breathing problems. It is not known if DUPIXENT is safe and effective in children with asthma under 6 years of age. [...] with other medicines for the maintenance treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) in adults and children 12 years of age and older whose disease is not controlled. [...] It is not known if DUPIXENT is safe and effective in children with chronic rhinosinusitis with nasal polyps under 12 years of age. [...] It is not known if DUPIXENT is safe and effective in children with eosinophilic esophagitis under 1 year of age, or who weigh less than 33 pounds (15 kg). [...] It is not known if DUPIXENT is safe and effective in children with prurigo nodularis under 18 years of age. [...] IMPORTANT SAFETY INFORMATION Do not use if you are allergic to dupilumab or to any of the ingredients in DUPIXENT®.

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5
Published in
United States of America