FDA issues CRL on Fasenra BLA in chronic rhinosinusitis with nasal polyps

Just as UK pharma major AstraZeneca (LSE: AZN) received a positive US regulatory decision for its breast cancer Lynparza (olaparib), the company was also delivered a setback, as the US Food and Drug Administration (FDA) 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. The CRL requested additional clinical data and the company is working closely with the FDA regarding next steps. The company says it remains committed to bringing Fasenra to patients with CRSwNP and a second Phase III trial,  ORCHID, in this indication is ongoing.

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