Regeneron Pharmaceuticals Inc. and Sanofi announced the FDA approval of dupilumab for adolescents aged 12 to 17 years with chronic rhinosinusitis with nasal polyps.
Dupilumab (Dupixent), a fully human monoclonal antibody that inhibits IL-4 and IL-13 signaling, will be used as an add-on maintenance treatment for adolescents with poorly controlled CRSwNP. Dupilumab was previously only approved for patients aged 18 years or older with inadequately controlled CRSwNP.
According to a press release by Sanofi, the approval was supported by positive results from the SINUS-24 and SINUS-52 studies. These