AstraZeneca/Sanofi Long-Acting RSV Antibody Beyfortus (Nirsevimab) Receives FDA Approval for Infant RSV Prevention

On July 17, Beyfortus (Nirsevimab), a long-acting respiratory syncytial virus (RSV) antibody jointly developed by AstraZeneca and Sanofi, was approved by the FDA for marketing to prevent lower respiratory tract disease (LRTD) caused by RSV in infants. The drug is suitable for newborns and infants born into or entering their first RSV season, as well as children under 24 months who are still at risk of severe RSV disease during their second RSV season. Beyfortus will be launched in the U.S. ahead of the upcoming 2023-2024 RSV season.

Nirsevimab, jointly developed by AstraZeneca and Sanofi, can protect infants from birth up to 24 months of age from RSV disease through a single injection.

On June 8, 2023, the FDA Antimicrobial Drugs Advisory Committee (AMDAC) unanimously voted 21 in favor and 0 against, concluding that Nirsevimab has a favorable benefit-risk profile for the prevention of RSV lower respiratory tract disease (LRTD) in newborns and infants entering or born during their first RSV season. Additionally, the committee supported Nirsevimab's favorable benefit-risk for children under 24 months with a vote of 19 in favor and 2 against, indicating its suitability for those who remain at risk of severe RSV disease during their second RSV season.

On November 4, 2022, Nirsevimab received its global first approval in the EU for use in newborns and infants to help prevent RSV lower respiratory tract infections during their first RSV season. This is the first and only single-dose passive immunization agent that can be widely applied to the infant population, including full-term or preterm healthy infants, as well as infants with special health conditions.

RSV is the most common cause of lower respiratory tract infections, with both the elderly and infants being susceptible populations. According to statistics, in 2019, about 101,000 children (0-5 years old) and 26,000 adults worldwide died from RSV infection. However, there is still no preventive solution for all infants and the elderly, and existing treatments are limited to symptom relief.

Notably, there have been frequent breakthroughs in the RSV field since 2023. On May 3, GSK announced that its RSV vaccine Arexvy (RSVPreF3 OA/GSK3844766A) had been approved by the FDA for market release to prevent lower respiratory tract diseases (RSV-LRTD) caused by RSV infection in the elderly population. This product is the world's first approved RSV vaccine. On May 31, Pfizer announced that its RSV vaccine ABRYSVO (RSVpreF, PF-06928316) had been approved by the FDA for market release to prevent RSV-LRTD in individuals aged 60 years and above.

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