AstraZeneca and Sanofi’s respiratory syncytial virus (RSV) drug has received positive feedback from the US Food and Drug Administration (FDA) staff. The drug, nirsevimab, is a monoclonal antibody that is designed to prevent RSV infections in infants.
RSV is a common respiratory virus that can cause serious illness in young children, especially those with weakened immune systems. It is estimated that RSV infections result in more than 57,000 hospitalizations and 2.1 million outpatient visits among children under the age of five in the United States each year.
Nirsevimab works by targeting the RSV fusion protein, which is essential for the virus to enter and infect cells. The drug is administered as a single injection and is designed to provide protection against RSV for up to six months.
The FDA staff review of nirsevimab was based on data from two clinical trials involving more than 3,000 infants. The trials showed that nirsevimab was effective in preventing RSV infections and reducing hospitalizations due to RSV.
In a statement, Mene Pangalos, Executive Vice President of BioPharmaceuticals R&D at AstraZeneca, said: “We are pleased with the positive feedback from the FDA staff and look forward to continuing to work with them as we seek approval for nirsevimab.”
Sanofi and AstraZeneca are currently seeking approval for nirsevimab from the FDA. If approved, nirsevimab would be the first RSV prevention therapy available for infants.
The positive feedback from the FDA staff is a promising development for Sanofi and AstraZeneca. RSV is a significant health concern for infants, and there is currently no approved vaccine or treatment for the virus. Nirsevimab has the potential to fill this gap and provide much-needed protection against RSV.
In addition to nirsevimab, Sanofi and AstraZeneca are also developing other monoclonal antibodies for the prevention and treatment of respiratory infections, including COVID-19. These efforts highlight the importance of investing in research and development to address global health challenges.
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