Posted by Michael Wonder on 14 Mar 2022
Update on US regulatory review of Fasenra in chronic rhinosinusitis with nasal polyps
14 March 2022 - The US FDA has issued a complete response letter regarding the supplemental biologics license application for Fasenra (benralizumab) for patients with inadequately controlled chronic rhinosinusitis with nasal polyps.
The supplemental biologics license application submitted to the FDA by AstraZeneca included data from the OSTRO Phase 3 trial, which met both co-primary endpoints with a safety profile consistent with the known profile of the medicine.
