Beyfortus contains the monoclonal antibody nirsevimab in a prefilled injection that is used to prevent lower respiratory tract disease (LRTD) in newborns and infants born during or entering their first RSV season, Sanofi said.
It is also administered in children up to 24 months who remain vulnerable to severe RSV disease through their second RSV season, it added.
RSV is a highly contagious virus that can lead to serious respiratory illness for infants.
Sanofi says 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,” the company said. In 2019, there were approximately 33 million cases of acute lower respiratory infections globally, leading to more than 3 million hospitalizations, and it was estimated that there were 26,300 in-hospital deaths of children younger than 5 years.In March 2017, Sanofi and AstraZeneca announced an agreement to develop and commercialise Beyfortus. Under the terms of the agreement, AstraZeneca leads development and manufacturing activities, and Sanofi leads commercialisation activities and records revenues.
Beyfortus is approved in the European Union, US, China, Japan, and other countries around the world.
“Prevention of RSV in India is still an unmet medical need, this makes the approval of Beyfortus a landmark moment for Sanofi in India,” said Preeti Futnani, general manager, Sanofi Vaccines (India).
“We are prioritising this potential game-changer to make Beyfortus available to all Indian parents to help protect their babies during their first and second RSV seasons,” Futnani added.
Dr Kuharaj Mahenthiran, country medical head, Sanofi Vaccines (India), added, that 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 programme 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,” said Mahenthiran
“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,” he added.
