what is this new treatment that could soon arrive in France?

Soon a preventive treatment against bronchiolitis? Every winter, in France, this highly contagious virus affects 30% of babies under two years old. On average, 2-3% of infants under the age of 1 are hospitalized each year because of this lower respiratory tract infection.

And this season the epidemic, due to the respiratory syncytial virus (RSV), was even more virulent, clogging the pediatric departments of hospitals.

The Sanofi laboratory, in partnership with the Astra-Zeneca laboratory, publishes this Friday, May 12 the results of a large study on the very first preventive treatment for bronchiolitis. According to the results, nirsevimab reduces the number of hospitalizations for bronchiolitis by 83.21% in infants who received a single dose, compared to infants who did not receive any preventive treatment.

A long-lasting antibody

The study was conducted during the RSV circulation season in 2022-2023, on more than 8,000 babies in France, Germany and the United Kingdom. “Throughout the HARMONIE study, nirsevimab exhibited a favorable safety profile, consistent with the results of the pivotal trials,” Sanofi said in its press release. That is, the risk-benefit has always favored one dose of nirsevimab.

This medicine is not a vaccine. It’s about ” of a long-acting antibody designed to protect all infants against RSV during their first season of exposure to the virus, at a single dose “. According to the European Medicines Agency, it is recommended to inject it into the thigh muscle.

“It is administered once before the start of the RSV circulation season or at birth for infants born during the RSV circulation season”, specifies the Health Agency on its website.

Available in France next year?

The drug, whose trade name is Beyfortus, already received marketing authorization from the European Union in October 2022, which was based on previous studies. For it to be available in France, the High Authority for Health must still give its green light, which could occur before the next RSV circulation season.

Sanofi and AstraZeneca are not alone in the ranks. Moderna is developing a treatment for pregnant women to protect newborns from severe forms of the disease.

Recently, the giant GSK received marketing authorization from the United States Medicines Agency for a vaccine for 60 year olds and more – they too are at risk of serious forms of respiratory disease from RSV. And the European Agency has already given it a favorable opinion.

Source : Sanofi, European Medicines Agency

Source: Le Progrès : info et actu nationale et régionale – Rhône, Loire, Ain, Haute-Loire et Jura | Le Progrès by www.leprogres.fr.

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