Sanofi (India) received approval from the Central Drugs Standard Control Organization (CDSCO) for the marketing of Beyfortus in India.
Beyfortus, which contains the monoclonal antibody nirsevimab, is a prefilled injection designed to prevent respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in newborns and infants entering their first RSV season.
It is also indicated for children up to 24 months who remain at risk for severe RSV disease during their second RSV season. RSV is a highly contagious virus that can cause significant respiratory illness in infants.
Approximately two-thirds of infants are infected with RSV within their first year, and nearly all children will have contracted it by their second birthday.
RSV is not only the leading cause of LRTD such as bronchiolitis and pneumonia in infants but also a major reason for hospitalizations worldwide, primarily affecting healthy, full-term infants.
In 201s9, global figures showed around 33 million cases of acute lower respiratory infections, leading to over three million hospitalizations, with an estimated 26,300 in-hospital deaths among children under five years old.