Sanofi has received the Central Drugs Standard Control Organization’s approval to market its respiratory syncytial virus (RSV) product Beyfortus in India.

Beyfortus contains the monoclonal antibody nirsevimab in a prefilled injection that is used to prevent RSV 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.

Sanofi India Managing Director Rodolfo Hrosz had told businessline, about three months ago, that Beyfortus was among the company’s “super-innovative therapies”  being evaluated for India.

RSV is highly contagious and can lead to serious respiratory illness in infants, the company said. 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, it added.

Beyfortus is approved in the European Union, the US, China, Japan, and other countries around the world. It is the first immunisation designed for all infants for protection against RSV through their first RSV season, including those born healthy at term or preterm, or with specific health conditions that make them vulnerable to RSV disease, Sanofi said.

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In addition to being the most common cause of LRTD such as bronchiolitis and pneumonia in infants, RSV is also a leading cause of hospitalisation in infants worldwide, with most hospitalisations occurring in healthy infants born at term, a note from the company said.  

 In 2019, there were approximately 33 million cases of acute lower respiratory infections globally, leading to more than three million hospitalisations, and it was estimated that there were 26,300 in-hospital deaths of children younger than five years, it said.

India data

 “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 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,” said Preeti Futnani, General Manager, Sanofi Vaccines (India).

Dr Kuharaj Mahenthiran, Country Medical Head, Sanofi Vaccines (India), added, “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. 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.”

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.

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