Sanofi (India) on Thursday announced that it has received marketing authorization approval from the Central Drugs Standard Control Organization (CDSCO) for Beyfortus in India.
The approval was granted on 10 June 2024. According to the company’s statement, Beyfortus contains the monoclonal antibody nirsevimab in a prefilled injection used for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in newborns and infants born during or entering their first RSV season. It is also administered in children up to 24 months of age, who remain vulnerable to severe RSV disease through their second RSV season.
RSV is a highly contagious virus that can lead to serious respiratory illness for infants. Two out of three infants are infected with RSV during their first year of life and almost all children are infected by their second birthday. In addition to being the most common cause of LRTD such as bronchiolitis and pneumonia in infants, RSV is also a leading cause of hospitalization in infants worldwide, with most hospitalizations occurring in healthy infants born at term.
“Prevention of RSV in India is still an unmet medical need. This makes the approval of Beyfortus a landmark moment for Sanofi in India. We are prioritizing this potential game-changer to make Beyfortus available for all Indian parents to help protect their babies during their first and second RSV seasons,” Preeti Futnani, General Manager – Sanofi Vaccines (India) said.
In 2019, there were approximately 33 million cases of acute lower respiratory infections globally, leading to more than three million hospitalizations, and it was estimated that there were 26,300 in-hospital deaths of children younger than 5 years.
“Data gathered from all geographical regions of India (from 1970 to 2020) to assess the burden of respiratory viruses and their prevalence, found RSV to be the most prevalent respiratory virus (29%) followed by Influenza Aix. The CDSCO approval for Beyfortus was based on a clinical program spanning three pivotal late-stage clinical trials. Across all clinical endpoints, a single dose of Beyfortus demonstrated high and consistent efficacy against RSV LRTD in all infant populations studied. These included babies born healthy at term, late preterm or preterm, or with specific health conditions that make them vulnerable to severe RSV disease. Beyfortus was also well tolerated with a favorable safety profile that was consistent across all clinical trials,” Dr. Kuharaj Mahenthiran, Country Medical Head, Sanofi Vaccines (India) said.
In March 2017, Sanofi and AstraZeneca announced an agreement to develop and commercialize Beyfortus. Under the terms of the agreement, AstraZeneca leads development and manufacturing activities, and Sanofi leads commercialization activities and records revenues. Beyfortus has been approved for use in the European Union, the US, China, Japan, and many other countries around the world.
