FDA Asks AstraZeneca More Questions About its Chronic Rhinosinusitis Drug

The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the supplemental Biologics License Application (sBLA) for AstraZeneca’s Fasenra (benralizumab) for patients with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP).

AstraZeneca said that the sBLA submitted to the FDA 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. The CRL requested additional clinical data and the company is working closely with the FDA regarding next steps. The company said that it remains committed to bringing Fasenra to patients with CRSwNP and a second Phase III trial, ORCHID, in this indication is ongoing.

Fasenra is currently approved as an add-on maintenance treatment for severe eosinophilic asthma in the US, EU, Japan and other countries and is approved for self-administration in the US, EU and other countries.

The FDA granted Orphan Drug Designation (ODD) for Fasenra for eosinophilic granulomatosis with polyangiitis in 2018, and hypereosinophilic syndrome and eosinophilic esophagitis (EoE) in 2019. In November 2021, the FDA also granted ODD for Fasenra for eosinophilic gastroenteritis (EGE) and eosinophilic gastritis (EG), and a Fast Track Designation for the treatment of EG with or without EGE in the US.