Sanofi's Beyfortus Receives Marketing Authorisation In India To Combat RSV In Infants

Sanofi (India) has received marketing authorisation approval from the Central Drugs Standard Control Organisation (CDSCO) for Beyfortus (nirsevimab) as of June 10, 2024, the company informed in a press statement on Friday.

Beyfortus is a monoclonal antibody administered via a prefilled injection, designed for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in newborns and infants entering their first RSV season, and in children up to 24 months of age vulnerable to severe RSV disease through their second RSV season.

RSV, a highly contagious virus, is known to cause serious respiratory illnesses in infants. Studies show that two out of three infants are infected with RSV within their first year, and nearly all children are infected by their second birthday. RSV is a leading cause of LRTD such as bronchiolitis and pneumonia in infants and is a major contributor to hospitalisation rates worldwide. In 2019, RSV was responsible for approximately 33 million cases of acute lower respiratory infections globally, leading to over 3 million hospitalisations and an estimated 26,300 in-hospital deaths in children under five.

Preeti Futnani, General Manager – Sanofi Vaccines (India), commented, “The prevention of RSV in India remains an unmet medical need. The approval of Beyfortus marks a significant milestone for Sanofi in India. We are committed to making Beyfortus available to Indian parents to protect their babies during their first and second RSV seasons.”

Kuharaj Mahenthiran, Country Medical Head, Sanofi Vaccines (India), added, “Data collected from across India from 1970 to 2020 indicates RSV as the most prevalent respiratory virus, affecting 29 per cent of the population, ahead of Influenza. The CDSCO approval for Beyfortus followed a comprehensive clinical program consisting of three pivotal late-stage trials. Beyfortus demonstrated high and consistent efficacy against RSV LRTD in various infant populations, including healthy term babies, late preterm or preterm infants, and those with conditions making them susceptible to severe RSV disease. The safety profile of Beyfortus was favourable and consistent across all trials.”

Beyfortus is already approved for use in the European Union, the US, China, Japan, and numerous other countries globally, the press statement added.