Anjali Sharma
GG News Bureau
NEW YORK, 3rd August. The Central Drugs Standard Control Organization on Friday has granted marketing authorization approval to Sanofi for Beyfortus, used for the prevention of respiratory syncytial virus (RSV), in India, the major drug company stated
RSV is a highly contagious virus that can lead to serious respiratory illness in infants and is also the leading cause of hospitalization in infants worldwide.
Sanofi said “Beyfortus contains the monoclonal antibody nirsevimab in a prefilled injection used for the prevention of RSV lower respiratory tract disease (LRTD) in newborns and infants born during or entering their first RSV season,”.
The monoclonal antibody can also be administered in children up to 24 months of age.
Preeti Futnani, General Manager of Sanofi Vaccines (India) said that “Prevention of RSV in India is still an unmet medical need. This makes the approval of Beyfortus a landmark moment for Sanofi in India.”
She noted the company is striving “to make Beyfortus available for all Indian parents to help protect their babies” against RSV.
Sanofi announced an agreement with AstraZeneca to develop and commercialise Beyfortus in March of 2017.
AstraZeneca will lead development and manufacturing activities, while Sanofi will look after commercialization activities and record revenues as per the agreement.
European Union, the US, China, and Japan are some of the countries where Beyfortus has been approved for use, media reported.
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