The Food and Drug Administration approved the monoclonal antibody treatment Beyfortus to prevent respiratory syncytial virus—the leading cause of hospitalizations in U.S. infants less than a year old.
The drug—made by AstraZeneca—will be administered as a single injection to infants prior to RSV season in the latter months of the year.
Beyfortus is a monoclonal antibody, meaning it provides proteins that imitate the immune system’s function to combat viruses like RSV.
Around 2% of children less than a year old are hospitalized by RSV every year, according to the American Academy of Pediatrics.
The FDA listed rash and injection site reactions as possible side effects of Beyfortus.
The drug received a fast track designation—a process meant to accelerate the review process of drugs that “fill an unmet medical need,” according to the FDA.
This is a developing story. Check back for updates.
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