2023-08-01 20:31:54
Agreement given for the Beyfortus. By a notice made public on Tuesday 1 August on its website, the High Authority for Health (HAS) said it was in favor of reimbursement for this preventive treatment against bronchiolitis, paving the way for its implementation before the next epidemic, expected for this fall. The Beyfortus had obtained, in November 2022, a favorable opinion from the European Commission.
Read also: Article reserved for our subscribers Bronchiolitis: new treatments soon available
Beyfortus is the trade name of nirsevimab, a synthetic monoclonal antibody developed by Sanofi and AstraZeneca laboratories. It differs from a vaccine in that it directly gives the body the means to fight against the respiratory syncytial virus (RSV), the main cause of bronchiolitis, instead of teaching it how to make them.
A single injection of Beyfortus provides protection for five months, according to its designers, enough to cover the entire epidemic season. Another treatment, palivizumab, marketed under the name Synagis by AstraZeneca since 1998, is already available for the cases most at risk – premature infants or infants suffering from cardiac and respiratory pathologies – but it requires one injection per month during the period. epidemic.
“Important medical need”
HAS notes that the French Neonatology Society and the Pediatric Infectious Pathology Group came out on June 5 in favor of a “routine administration of one dose of nirsevimab to all infants under 6 months of age at the start of the next epidemic period”. As for the most vulnerable newborns, these learned societies, reminds the HAS, “propose to extend this prophylaxis to infants under 12 months of age” and prefer nirsevimab to palivizumab “due to its efficacy, similar safety profile and simplified injection schedule”.
“Given the sometimes serious nature of RSV, its contagiousness, the impact on the organization of care, in particular on intensive care units, there is a significant medical need to have effective and well-tolerated drugs in the infection prevention »also notes the HAS in its opinion, adding that“to date the medical need is insufficiently covered”.
According to one study published by The Lancet in May 2022bronchiolitis kills 160,000 people every year, and children under 5 account for three-quarters of the victims.
Read also: Bronchiolitis: European regulator approves first vaccine to protect infants
#agreement #France #reimbursement #preventive #treatment #Beyfortus