Sanofi India announced the receipt of marketing authorization for Beyfortus (nirsevimab) from the Central Drugs Standard Control Organization (CDSCO) on June 10, 2024
Beyfortus is a monoclonal antibody, delivered via a prefilled injection, aimed at preventing respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in newborns and infants born during or entering their first RSV season
Additionally, it is administered to children up to 24 months who remain at risk for severe RSV disease through their second RSV season
RSV: A Major Threat to Infant Health
RSV is a highly contagious virus that can cause severe respiratory illness in infants. Two out of three infants contract RSV within their first year, and nearly all children are infected by their second birthday. RSV is the leading cause of LRTD, such as bronchiolitis and pneumonia, in infants and is a significant cause of hospitalization among healthy, full-term infants worldwide.
In 2019, approximately 33 million cases of acute lower respiratory infections were reported globally, resulting in over 3 million hospitalizations and an estimated 26,300 in-hospital deaths of children under five years old.
Development and Global Approval of Beyfortus
In March 2017, Sanofi and AstraZeneca formed an agreement to develop and commercialize Beyfortus. Under this collaboration, AstraZeneca oversees development and manufacturing, while Sanofi handles commercialization and revenue recording. Beyfortus has already been approved for use in the European Union, the US, China, Japan, and numerous other countries.
About Beyfortus
Beyfortus (nirsevimab) is the first immunization specifically designed to protect all infants from RSV during their first RSV season, including those born healthy at term, preterm, or with specific health conditions that increase their susceptibility to RSV. It also protects children up to 24 months who are at risk for severe RSV disease during their second RSV season.
As a long-acting antibody, Beyfortus is administered directly to newborns and infants in a single dose, providing rapid protection against LRTD caused by RSV without requiring the activation of the immune system. The timing of Beyfortus administration can be coordinated with the start of the RSV season.
With this latest approval in India, Sanofi continues its mission to safeguard infants and young children from the severe consequences of RSV, reinforcing its commitment to public health and pediatric care.
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