Sanofi and AstraZeneca have obtained approval from the US Food and Drug Administration (FDA) for their antibody Beyfortus (nirsevimab) as a preventative measure against lower respiratory tract disease caused by respiratory syncytial virus (RSV) in infants. This approval applies to newborns, infants in their first RSV season, and young children up to 24 months old who remain at risk of RSV during their second disease season. This regulatory clearance positions Sanofi and AstraZeneca as key players in the RSV field, which has recently witnessed Pfizer and GSK securing consecutive FDA approvals for their adult vaccines.
The objective of the partnership is to make Beyfortus available in the US before the upcoming 2023-24 RSV season, thereby addressing a significant health concern for infants across the country. RSV is a primary cause of hospitalizations among infants under one year old, with hospitalization rates approximately 16 times higher than those attributed to influenza. Every year, around 590,000 newborns in the US necessitate medical care due to RSV-related illnesses.
Sanofi has been eagerly awaiting US approval for Beyfortus as it is a crucial component of the company’s broader immunization strategy. With a goal of generating over 10 billion euros in annual immunization sales by 2030, Sanofi aims to establish itself as a leader in RSV prevention. In addition to Beyfortus, the company is also developing two experimental vaccines to target RSV across various populations.
Kimberly Tutwiler, head of Sanofi’s RSV franchise, emphasized the significance of FDA approval for Beyfortus in infants, stating that it lays the foundation for their RSV aspirations. Manufacturing of the drug is already underway in the US, and Sanofi expects to meet the demand for the upcoming RSV season. Tutwiler highlighted the anticipation among physicians and public health experts who have long been awaiting a solution for RSV that can be offered to a broader population of infants.
The FDA’s decision was widely expected following a positive review by an advisory committee last month. The committee unanimously voted in favor of Beyfortus, affirming its favorable benefit-risk profile in protecting against RSV-associated lower respiratory disease in infants during their first RSV season. The antibody also received strong support (19 to 2) for its benefit-risk profile in children up to 24 months old, who remain vulnerable to RSV during their second season.
Clinical trials demonstrated that a single dose of Beyfortus exhibited high and consistent efficacy against RSV lower respiratory tract disease for up to five months, which aligns with the typical duration of an RSV season. Apart from approvals in Europe, the US, the UK, and Canada, the drug is currently undergoing review in Japan & China as well as other countries.
The approval of Beyfortus by Sanofi and AstraZeneca marks a significant stride in their efforts to combat RSV and strengthen their position in the immunization market. The availability of this preventive treatment for infants will help safeguard vulnerable populations from the severe consequences of RSV, ultimately contributing to improved infant health and well-being.