On July 17, 2023, it was announced by the U.S. Food and Drug Association have approved Sanofi and AstraZeneca’s jointly developed medicine Beyfortus (nirsevimab-alip) for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in newborns and infants.
RSV is a virus that affects people of all ages, causing short-term respiratory infections in them. RSV usually only brings mild symptoms such as cold and cough in most infants and children.
However, it has been shown to be more harmful to some infants – causing lower respiratory tract disease in them, which might require hospitalization. This is especially true for infants dealing with their first infection. They might develop lower respiratory tract diseases such as bronchiolitis and pneumonia – which can be critical.
Additionally, premature infants, infants with congenital heart disease and infants with chronic lung disease are at the highest risk of suffering from these diseases. With RSV being the leading cause of hospitalization of infants under 12 months of age, the need to fight the disease is urgent.
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The recent approval of Beyfortus by the FDA aims to reduce these risks and infections and will be incredibly helpful for developing a strong immunity against RSV in newborns and infants up to 24 months of age – preventing these critical diseases in them.
The approval for Beyfortus comes after extensive clinical trials which showed that a single dosage of is highly and consistently effective against RSV Lower Respiratory Tract Disease. Additionally, it showed an overall favourable safety profile.
“Beyfortus represents an opportunity for a paradigm-shift in preventing serious respiratory disease due to RSV across a broad infant population in the U.S.” - Iskra Reic, Executive Vice President, Vaccines and Immune Therapies, AstraZeneca.
The U.S. is now the latest country to have approved Beyfortus. It was previously approved in the European Union and Great Britain in 2022, and in Canada in 2023. In countries like Japan and China, regulatory applications for Beyfortus are under review.
The results and performance of Beyfortus will be put to the test when the U.S. enters the peak RSV season, which usually lasts from fall to winter.