Update on US regulatory review of Fasenra in 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 CRL requested a…

Read the full story at https://www.webwire.com/ViewPressRel.asp?aId=286529

Source: Webwire.com
Update on US regulatory review of Fasenra in chronic rhinosinusitis with nasal polyps