FDA Panel Endorses AstraZeneca and Sanofi's RSV Drug for Infants
Key Insights
An FDA advisory panel has unanimously endorsed AstraZeneca and Sanofi's nirsevimab for preventing RSV in newborns and infants.
The long-acting monoclonal antibody, Beyfortus, requires only a single dose, potentially improving uptake and real-world efficacy.
The panel also voted in favor of its use for children up to two years old, though with some reservations regarding further research.
A panel of advisors to the Food and Drug Administration (FDA) has voted in favor of a drug developed by AstraZenecaView company profile and SanofiView company profile to prevent respiratory syncytial virusSearch disease (RSVSearch disease) in infants. The advisory committee's decision supports the use of the drug, potentially marking a significant advancement in pediatric healthcare.
The Antimicrobial Drugs Advisory Committee voted unanimously to endorse the medicine for newborns and infants, citing a compelling safety profile. Douglas Diekema, a temporary advisory committee member and professor of pediatrics at the University of Washington in Seattle, emphasized the importance of addressing a disease that affects almost every child before the age of two, highlighting the impact on families, children, and the healthcare system. He stated he was convinced by the efficacy data and reassured by the safety data.
The long-acting monoclonal antibody, known as BeyfortusSearch drug (nirsevimabSearch drug), is designed to prevent RSVSearch disease in newborns and infants during their first RSV season, typically spanning the winter months. A key advantage of the drug is its single-dose administration, which committee members believe could enhance uptake and real-world efficacy.
The panel also voted 19-2 to support the antibody’s use for children up to two years old who remain vulnerable to the disease during their second RSVSearch disease season. Sally Hunsberger, a committee member and biostatistician at the National Institutes of Health, voted a "weak no," advocating for further research on the drug's use in populations including those with congenital heart disease.
Thomas Triomphe, Sanofi’s executive vice president of vaccines, expressed encouragement regarding the advisory committee’s positive vote, emphasizing the potential of nirsevimabSearch drug to reduce the annual RSVSearch disease burden. Iskra Reic, AstraZeneca’s executive vice president of vaccines and immune therapies, stated that the drug builds on AstraZeneca’s strong science, leadership in RSV, and commitment to addressing the needs of the most vulnerable.
RSVSearch disease is the primary cause of hospital admissions for babies under one year old, with most children contracting the disease before the age of two. Scientists and doctors have been pursuing vaccines and drugs against RSV for over 60 years, recognizing its substantial health burden in both young children and older adults. The FDA recently approved two vaccines for older adults from GSK PlcView company profile and Pfizer Inc.View company profile, and a maternal vaccine from Pfizer aimed at protecting babies is expected to receive clearance this year. Bloomberg Intelligence estimates the market for RSV vaccines in older adults alone could reach $10 billion within the next decade.
Prior to these recent breakthroughs, AstraZenecaView company profile had an older drug that provided passive immunization for infants at risk of severe RSVSearch disease. However, this antibody offered only short-term protection and required multiple injections.