(CercleFinance.com) – AstraZeneca announces that the U.S. Food and Drug Administration (FDA) has issued a Comprehensive Response Letter (CRL) regarding the Supplemental Biologics License Application (sBLA) for Fasenra (benralizumab) how to treat chronic rhinosinusitis with nasal polyps (CRSwNP).
Although the sBLA submitted to the FDA by AstraZeneca included data from a Phase III trial, the FDA, through its comprehensive response letter, requested additional clinical data.
AstraZeneca therefore indicates that a second phase III trial in this indication is underway.
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