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RSV drug nirsevimab chases FDA approval

Words by GOLD newsdesk

A drug to treat infants with respiratory syncytial virus (RSV) is on its pathway to approval in the US following a successful Biologics License Application to the FDA.


Developed by Sanofi and AstraZeneca, nirsevimab would be the first broadly protective option against RSV designed for all infants to be approved in the US. This includes infants born healthy, at term or preterm, or with specific health conditions.


The treatment was approved in the UK and Europe towards the end of 2022, and it could be a lifeline to the US as high levels of infant deaths by RSV are currently being recorded. Globally, one in 50 deaths of otherwise healthy children under the age of five were due to the disease in 2022.


“In the US, we’ve seen first-hand how frightening the impact of this respiratory disease is on our patients and how stressful it is on the healthcare system,” said Dr William Muller, Associate Professor, Pediatrics, Northwestern University Feinberg School of Medicine, adding that these two factors combined highlights “the urgency of addressing this problem”.


The FDA has said it will work to expedite its review of nirsevimab, and Sanofi bosses hope it will be available in the US shortly. “It is our intention to make nirsevimab available, if approved in time, for the 2023/2024 season to help alleviate the burden of RSV on families and the healthcare system,” said Thomas Triomphe, Executive Vice President, Vaccines, Sanofi.


The drug delivers consistent protection of approximately 80% against medically attended RSV disease. This is RSV illness in which the patient attends a doctor’s surgery, A&E, or a hospital.

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