WASHINGTON – The Food and Drug Administration has approved a new monoclonal antibody to protect infants from RSV.
The infection is the top cause of infant hospitalization in the U.S. and can be fatal.
The therapy, Enflonsia, is made by Merck.
It’s given a single 105-milligram shot to protect newborns and infants from RSV through their first virus season.
In a mid-to-late stage trial, it reduced RSV associated hospitalizations in infants by more than 84% compared with a placebo.
Merck hopes Enflonsia will be available before the start of the 2025-2026 respiratory virus season.
First, the Centers for Disease Control and Prevention needs to recommend it.
