Posted by Michael Wonder on 13 Sep 2024
Dupixent (dupilumab) approved in the US as first and only treatment for adolescents with chronic rhinosinusitis with nasal polyps
13 September 2024 - Regeneron Pharmaceuticals and Sanofi today announced that the US FDA has approved Dupixent (dupilumab) as an add-on maintenance treatment for adolescent patients aged 12 to 17 years with inadequately controlled chronic rhinosinusitis with nasal polyps.
This approval expands the initial June 2019 FDA approval in chronic rhinosinusitis with nasal polyps. for patients aged 18 years and older. The FDA evaluated Dupixent for this expanded indication under priority review, which is reserved for medicines that represent potentially significant improvements in efficacy or safety in treating serious conditions.
