Nirsevimab, the first approved preventive treatment against the respiratory syncytial virus that causes bronchiolitis, would have prevented 83.21% of hospitalizations in babies under one year old. This observation is the result of a phase three study carried out on more than 8,000 children in France, Germany and the United Kingdom.
The French laboratory Sanofi claimed Friday “very promising results” after a large study carried out on its preventive treatment nirsevimab, co-developed with the British AstraZeneca, aimed at reducing the risk of hospitalization for infants with respiratory syncytial virus (RSV). This drug, the first preventive treatment in the world approved against RSV, the cause of bronchiolitis, made it possible “to avoid 83.21% of hospitalizations in infants under twelve months who received a single dose of nirsevimab, compared to to infants who have not received any intervention” against the virus, Sanofi said in a statement.
Marketing authorization
This finding is the result of a phase three study carried out on more than 8,000 children in France, Germany and the United Kingdom, using data collected in real situations during the 2022-2023 RSV circulation season. “The overall burden on healthcare systems could be significantly reduced if nirsevimab were given to all infants. suite) amounted, according to estimates, to 4.82 billion euros” on a global scale, underlines Sanofi.
Currently, nine out of ten children are infected with RSV before the age of two. Although the infection is generally not serious, nearly one in three children who present to the emergency room for bronchiolitis require hospitalization. According to the French national study carried out from 2010 to 2018, an average of 50,878 children under the age of five are hospitalized because of RSV each year. Among them, children under the age of one represent more than 69% of hospitalizations, or more than 35,000 children per year, recalls Sanofi.
So far, nirsevimab has obtained marketing authorization in the European Union, United Kingdom and Canada for the prevention of lower respiratory tract infections caused by respiratory syncytial virus in neonates and infants. infants during their first RSV exposure season. In addition, its request for approval in the United States is under consideration.
Source: Europe1
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