Update on US review of Fasenra in nasal polyps
14 March 2022 07:00 GMT Update on US regulatory review of Fasenrain chronic rhinosinusitis with nasal polyps The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the supplemental Biologics License Application (sBLA) for Fasenra (benralizumab) for patients with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). The sBLA submitted to the FDA by AstraZeneca included data from the OSTRO Phase III trial, which met both co-primary endpoints with a safety profile consistent with the known profile of the medicine.[1] The