FDA refuses to approve AstraZeneca’s sBLA for Fasenra in CRSwNP

The US Food and Drug Administration (FDA) has refused to approve the supplemental biologics license application (sBLA) of AstraZeneca’s asthma drug Fasenra (benralizumab) for the treatment of patients having inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP).

The US pharma regulator has issued a complete response letter (CRL) to AstraZeneca, seeking more clinical data on the benefits of Fasenra in CRSwNP.

AstraZeneca’s sBLA included data from the OSTRO phase 3 clinical trial. The late-stage clinical trial in patients with nasal polyposis met both co-primary endpoints with a safety profile that was on par with the known profile of the drug.

The UK-based pharma giant stated: “The CRL requested additional clinical data and the Company is working closely with the FDA regarding next steps. The Company remains committed to bringing Fasenra to patients with CRSwNP and a second Phase III trial, ORCHID, in this indication is ongoing.”

Presently, Fasenra is approved as an add-on maintenance treatment for patients having severe eosinophilic asthma in the US, European Union (EU), Japan, and other countries.

In 2018, Fasenra was granted orphan drug designation (ODD) by the FDA for eosinophilic granulomatosis with polyangiitis. The following year saw the monoclonal antibody approved for the treatment of hypereosinophilic syndrome and eosinophilic esophagitis (EoE).

Last November, the US pharma regulator also issued ODD for Fasenra for its use in eosinophilic gastroenteritis (EGE) and eosinophilic gastritis (EG). The AstraZeneca respiratory drug also has FDA fast track designation for the treatment of eosinophilic gastritis with or without eosinophilic gastroenteritis.