Sanofi (India) received approval from the Central Drugs Standard Control Organisation (CDSCO) to market Beyfortus in India. Beyfortus, a prefilled injection containing the monoclonal antibody nirsevimab, is designed to prevent lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in newborns and infants during their first RSV season. It is also used for children up to 24 months old who are at risk of severe RSV disease during their second RSV season.
Globally, acute lower respiratory infections affected around 33 million people in 2019, leading to over 3 million hospitalizations and an estimated 26,300 in-hospital deaths among children under 5 years of age.
Preeti Futnani, General Manager of Sanofi Vaccines (India) commented, “The approval of Beyfortus marks a significant milestone for Sanofi in India, addressing a crucial need for RSV prevention. We are committed to making Beyfortus accessible to Indian parents to help safeguard their babies during their initial and second RSV seasons”.
Dr. Kuharaj Mahenthiran, Country Medical Head at Sanofi Vaccines (India), added, “Our extensive data analysis from 1970 to 2020 indicates that RSV is the most prevalent respiratory virus in India, accounting for 29% of cases, followed by Influenza A. The CDSCO’s approval of Beyfortus is supported by a comprehensive clinical program, including three major late-stage trials. These studies demonstrated that a single dose of Beyfortus is highly effective in preventing RSV LRTD across various infant populations, including those born healthy at term, late preterm, or with specific health conditions that heighten their risk. Beyfortus also showed a favorable safety profile in these trials”.
In March 2017, Sanofi and AstraZeneca entered into an agreement to develop and commercialize Beyfortus, with AstraZeneca handling development and manufacturing, while Sanofi manages commercialization and revenue generation. As reported by biospectrumindia.com, Beyfortus has already been approved in the European Union, the US, China, Japan, and several other countries globally.