FDA accepts application for nirsevimab as first protective option for RSV in infants

pharmafile | January 5, 2023 | News story | Medical Communications  

The FDA has accepted an application for nirsevimab as the first protective option to combat respiratory syncytial virus (RSV) disease for all infants. If approved, the drug would become the first broadly protection option for RSV.

According to the clinical trials assessing nirsevimab, the drug provided consistent protection of around 80% against medically-attended RSV disease in both healthy term and preterm infants. It has already been approved under accelerated review in both the EU and the UK.

The drug is intended to protect newborns and infants up to the age of 24 months who are vulnerable when entering their first and second RSV seasons. It has been developed jointly by Sanofi and AstraZeneca and would be the first protective option available for the entire infant population, including those born healthy, at term or preterm, and those with specific health conditions.

Thomas Triomphe, executive vice president of vaccines at Sanofi, commented: “This is a landmark file acceptance in the US as it brings us one step closer to offering the first and only broadly protective option against RSV disease designed for all infants. Given the unprecedented number of otherwise healthy infants who have been hospitalised with RSV this year in the US, and the recurrent patent of RSV epidemics year after year, 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.”

Dr William Muller, associate professor of paediatrics at Northwestern University Feinberg School of Medicine, and scientific director of clinical and community trials at Ann & Robert H. Lurie Children’s Hospital of Chicago, Illinois, said, “a substantial burden of disease from RSV affects infants, families, and healthcare providers every year. Effective interventions to prevent RSV are a critical need. This year 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, highlighting the urgency of addressing this problem.”


Betsy Goodfellow

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