Nirsevimab Receives Unanimous FDA Advisory Committee Support for RSV Prevention in Infants

On June 9, Sanofi announced that the FDA Advisory Committee voted 21:0 to support the approval of Nirsevimab, a long-acting respiratory syncytial virus (RSV) antibody jointly developed with AstraZeneca. It is intended for the prevention of RSV infection in newborns and infants entering or born during their first RSV season. The FDUFA date is set for the third quarter of 2023.

Nirsevimab is a long-acting monoclonal antibody jointly developed by AstraZeneca and Sanofi for all infants, which can protect them from RSV disease through a single injection from birth to their first RSV season.

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 in preventing RSV lower respiratory tract disease (LRTD) and is suitable for newborns and infants who are about to enter or are born during their first RSV infection season.In addition, the committee supported the favorable benefit-risk profile of Nirsevimab for children under 24 months of age, who remain vulnerable to severe RSV disease during their second RSV season, with a vote of 19 in favor and 2 against.

On November 4, 2022, Nirsevimab received its global first approval in the EU under the brand name Beyfortus, for use in newborns and infants to help prevent RSV lower respiratory tract infections during their first respiratory syncytial virus (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 premature healthy infants, as well as infants with special health conditions.

RSV is the most common cause of lower respiratory tract infections, with the elderly and infants being the most susceptible populations. According to statistics, in 2019, approximately 101,000 children (aged 0-5 years) and 26,000 adults globally died from RSV infections. However, there are still no preventive solutions available for all infants and the elderly, and current treatment options are limited to alleviating symptoms.

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 marketing to prevent lower respiratory tract disease (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 marketing to prevent RSV-LRTD in people aged 60 years and above.

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