This is a new step in the fight against respiratory syncytial virus (RSV), responsible for the majority of cases of bronchiolitis that affect infants and the elderly during the winter. The Sanofi laboratory, ociated with AstraZeneca, published new results on Friday May 12 showing that nirsevimab, its monoclonal antibody which will be marketed under the name Beyfortus, had an even stronger efficacy than the first clinical trials had hoped. .
The Harmonie study, conducted on 8,000 children in four European countries during the last epidemic season, between September 2022 and February 2023, shows an 83% drop in RSV-related hospitalizations in children under one year old thanks to with a simple injection of this product. Previous clinical studies showed an already strong efficacy, at 79%. ” It is a surprise. Usually, real-life studies always have lower results than clinical studies”enthuses Pierre Tissières, head of the pediatric intensive care unit at Bicêtre hospital, in Kremlin-Bicêtre (Val-de-Marne) and author of the study.
A new success for the two laboratories, which had already obtained in November 2022 European Commission approval for nirsevimab, an essential prerequisite for its deployment in the Member States. In the race between laboratories to fight against RSV in infants, nirsevimab thus outweighs the vaccines under development. This is a synthetic antibody treatment allowing pive immunization of infants. Unlike vaccines, which teach the body to make its own antibodies, monoclonal antibodies directly provide weapons to fight viruses.
“Prevention from birth”
“The study shows that we can launch an RSV prevention strategy from birth, since half of the children recruited were in maternity, at less than three months”, insists Pierre Tissières. And this in all infants. For the moment, the only monoclonal antibody against RSV available in France for twenty-five years, palivizumab, marketed under the name Synagis by AstraZeneca, is only recommended for children born prematurely and/or suffering from cardiac pathologies and respiratory.
The question now is whether and when nirsevimab will be available in France. “We have the means to ensure that the impact of the next outbreak of bronchiolitis is modest; it all depends on the responsiveness of the health authorities”, argues Pierre Tissières. An estimated 50,000 bronchiolitis-related hospitalizations each year. Reducing this figure by 83% would be a major game-changer for the hospital system. Discussions are underway between the manufacturer and the French government. “The objective is for the product to be available in France from next winter, which is a challenge, because between the marketing authorization and the arrival in the countries, the discussions take rather a year and a half. in general “we say at Sanofi.
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