FDA rejects benralizumab application for chronic rhinosinusitis with nasal polyps

AstraZeneca has received an FDA complete response letter concerning its supplemental biologics license application for benralizumab for the treatment of inadequately controlled chronic rhinosinusitis with nasal polyps.
The FDA asked for additional clinical data in the response letter.
The application included data from the phase 3 OSTRO trial, which met both of its co-primary endpoints with a safety profile consistent with the known profile of benralizumab (Fasenra), a humanized, afucosylated monoclonal antibody that binds to cells that express the IL-5 receptor. Changes from baseline to week

AstraZeneca has received an FDA complete response letter concerning its supplemental biologics license application for benralizumab for the treatment of inadequately controlled chronic rhinosinusitis with nasal polyps.
The FDA asked for additional clinical data in the response letter.
The application included data from the phase 3 OSTRO trial, which met both of its co-primary endpoints with a safety profile consistent with the known profile of benralizumab (Fasenra), a humanized, afucosylated monoclonal antibody that binds to cells that express the IL-5 receptor. Changes from baseline to week