The French pharmaceutical group Sanofi has announced on Monday that it has received the green light from the US Medicines Agency (DFA) for its preventive treatment for bronchiolitis for newborns, Beyfortus, developed with the British laboratory AstraZeneca.
This monoclonal antibody (nirsevimab) aims to protect babies against the respiratory syncytial virus (RSV), responsible for bronchiolitis, which returns every winter and infects a large proportion of children under 2 years of age.
US authorities have given this treatment the green light for babies born during the virus season or at the beginning of their first season of exposure to the virus, as well as for children up to 2 years of age during their second season of exposure to the virus. virus, Sanofi said in a statement.
This last indication, already approved in Canada, is currently being reviewed by the European Medicines Agency.
lasting efficiency
Clinical results showed that a single dose of Beyfortus demonstrated consistent and long-lasting high efficacy against RSV infections over a prolonged period of five months, corresponding to the length of seasonal virus circulation, generally from October to February. /March.
Sanofi and AstraZeneca plan to “commercialize Beyfortus in the US market before the start of the next viral season (2023-2024)”, according to the group, which recalls that in the United States, RSV is the leading cause of hospitalization for babies under 12 months of age. .
Recently questioned by AFP, Sanofi’s head of vaccine research and development, Thomas Triomphe, had indicated that “several hundred thousand doses (were) already ready for shipment”, produced for Europe and North America.
Beyfortus has obtained marketing authorization in the European Union, the United Kingdom and Canada for the prevention of RSV infections in newborns and infants during their first season of exposure to RSV.
Source: BFM TV
