Sanofi Receives Drug Regulator Approval To Market RSV therapy in India

Sanofi, a pharmaceutical company from France, announced that the Central Drugs Standard Control Organization (CDSCO) in India has approved the marketing of their new treatment Beyfortus for newborns and infants with respiratory syncytial virus (RSV).

Sanofi stated that Beyfortus has nirsevimab monoclonal antibody in a pre-filled injection for preventing lower respiratory tract disease (LRTD) in newborns and infants entering their first RSV season.

It is also given to children up to 24 months old who are still at risk for serious RSV illness during their second RSV season, it stated. RSV is an extremely infectious virus that can result in severe respiratory illness in babies. Sanofi reports that 66% of infants contract RSV in their first year, and nearly all children are infected by age two.

"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.

Around 33 million instances of acute lower respiratory infections were recorded worldwide in 2019, resulting in over 3 million hospitalizations, with an estimated 26,300 in-hospital deaths of children under 5 years old.

During March of 2017, Sanofi and  leading pharmaeutical firm AstraZeneca disclosed a deal to collaborate on the advancement and distribution of Beyfortus. According to the agreement, AstraZeneca is responsible for development and manufacturing, while Sanofi handles commercialization and revenue tracking.