Sanofi India's Beyfortus Gets CDSCO Approval for RSV Prevention

Sanofi India has received marketing authorisation from the CDSCO for Beyfortus, a drug that prevents Respiratory Syncytial Virus (RSV) and Lower Respiratory Tract Disease (LRTD) in infants and young children. This approval marks a significant milestone for RSV prevention in India.

Sanofi India announced on Thursday that it has received marketing authorisation from the Central Drugs Standard Control Organisation (CDSCO) for its drug Beyfortus in India.

Beyfortus, designed to prevent Respiratory Syncytial Virus (RSV) and Lower Respiratory Tract Disease (LRTD), is administered to newborns, infants, and children up to 24 months of age, who are at high risk of severe RSV disease during their second RSV season.

Preeti Futnani, General Manager of Sanofi Vaccines (India), stated that the prevention of RSV remains an unmet medical need in India, making this approval a landmark achievement for the company. Sanofi and AstraZeneca, who entered into an agreement in March 2017, have spearheaded the development, manufacturing, and commercialisation of Beyfortus.

(With inputs from agencies.)