FDA adcomm votes unanimously in favor of AstraZeneca's preventive mAb for RSV in infants
The FDA’s Antimicrobial Drugs Advisory Committee voted 21-0 in favor of the benefit-risk profile of AstraZeneca’s nirsevimab, a monoclonal antibody intended to prevent respiratory syncytial virus (RSV) in infants born during or entering their first RSV season.
Committee members explained how RSV can lead to significant illness, hospitalization and deaths for young children, creating a clear need for another drug, and the trial data show the product will prevent a significant number of RSV cases.
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