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FDA to Review a Preventative RSV Treatment


The news that the FDA accepted licensing application from Astrazeneca/Sanofi for its expedited review for a single-dose long-acting antibody (Nirsevimab) is highly encouraging. This is indicated to prevent Respiratory Syncytial Virus (RSV) infections in newborns and infants entering or during their first RSV season, as well as children aged up to 24 months who are vulnerable to severe RSV disease through to their second RSV season.


Nirsevimab demonstrated up to 74.5% reduction in lower-respiratory tract infections, such as bronchiolitis or pneumonia, caused by RSV, and would become the first and only single-dose, passive immunization for a broad newborn and infant population in the US. This brings us one step closer to providing an effective protective option against this incredibly contagious disease responsible for the hospitalization of babies less than 1 year of age. This has already been approved in Europe and if everything goes well, it is expected to be approved in the US by the third quarter – just in time for the 2023/24 RSV season. Till then, scientists reiterate the importance of quickly and properly identifying pathogens by using tests like Acutis Reveal™ respiratory infection test (RIT) that can detect up to 22 major respiratory pathogens including RSV A and B within 24 hours.


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