Novel Antiviral Gets Breakthrough Therapy Status for Universal Flu Protection
The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to CD388 for seasonal influenza prevention in adults and adolescents at higher risk of influenza complications.
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.
- Prevention of influenza A and B in adults and adolescents with underlying immunodeficiency
- Prevention of severe influenza despite influenza vaccination
- Protection for those for whom vaccines are contraindicated
The Breakthrough Therapy designation is supported by data from the phase 2b NAVIGATE trial.
Author's summary: CD388 granted Breakthrough Therapy status for universal flu protection.