The U.S. Food and Drug Administration advisers on Thursday backed the use of Sanofi and partner AstraZeneca's experimental antibody to prevent respiratory syncytial virus (RSV) infections in infants.
The advisers voted unanimously in favor of using the antibody, nirsevimab, in newborns and infants to prevent infections in their first RSV season.
In a separate 19-2 vote, the panel backed the therapy's use in children aged up to two years who are vulnerable to severe illness through their second RSV season.treatment Synagis is currently the only approved preventive therapy in the United States for high-risk infants against RSV, a leading cause of hospitalizations during an infant's first year of life.
Unlike Synagis, which is given as monthly injections, nirsevimab is a long-acting therapy expected to be given once every season to prevent infection regardless of additional medical conditions in infants. "This is probably the closest thing to an RSV vaccine that we have and it really moves the field forward," said panel member Nimish Patel.
Two studies showed the therapy was effective in preventing lower respiratory tract infections, the FDA staff reviewers had
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