Novel Antiviral Gets Breakthrough Tx Status for Universal Flu Protection
The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to CD388 for seasonal influenza prevention.
CD388 is intended for the prevention of influenza A and B in adults and adolescents who are at higher risk of influenza complications due to underlying immunodeficiency, are at higher risk of severe influenza despite influenza vaccination, or those for whom vaccines are contraindicated.
CD388 is an investigational drug-Fc conjugate that combines zanamivir, a neuraminidase inhibitor, with a human antibody fragment, expected to provide protection against all known strains of seasonal influenza with a single dose.
The Breakthrough Therapy designation is supported by data from the phase 2b NAVIGATE trial.
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Author's summary: FDA grants Breakthrough Therapy designation to CD388 for flu prevention.