2023-07-17 18:16:02
Paris (awp/afp) – The French pharmaceutical group Sanofi announced on Monday that it had received the green light from the American drug agency (DFA) for its preventive treatment for bronchiolitis intended for newborns, Beyfortus, developed with the British laboratory AstraZeneca.
This monoclonal antibody (nirsevimab) aims to protect babies once morest the respiratory syncytial virus (RSV), responsible for bronchiolitis, which returns every winter and infects a large proportion of children under 2 years old.
This treatment has been given the green light by US authorities for babies born during virus season or at the start of their first season of exposure to the virus, as well as for children up to age 2 during their second season of exposure. exposure to the virus, Sanofi said in a statement.
This last indication, already approved in Canada, is currently being reviewed by the European Medicines Agency.
Clinical results showed that a single dose of Beyfortus demonstrated consistent, long-lasting high efficacy once morest RSV infections over an extended period of five months, which corresponds to the seasonal circulation duration of the virus, usually running from October to February/March.
Sanofi and AstraZeneca plan to “market Beyfortus on the American 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 first cause of hospitalization of infants under 12 months.
Recently questioned by AFP, the head of research and development of vaccines at Sanofi, Thomas Triomphe, had indicated that “several hundred thousand doses (were) already ready for dispatch”, produced for Europe and North America.
Beyfortus has obtained marketing authorization in the European Union, United Kingdom and Canada for the prevention of RSV infections in newborns and infants during their first season of RSV exposure .
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