The US health regulator gave its approval after the Antimicrobial Drugs Advisory Committee (AMDAC) unanimously voted in favour of Beyfortus' favourable benefit-risk profile
FDA clears Beyfortus for RSV infection prevention in infants. (Credit: Wes Hicks on Unsplash)
The US Food and Drug Administration (FDA) has approved AstraZeneca and Sanofi’s Beyfortus (nirsevimab) to prevent respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in newborns and infants born during or entering their first RSV season.
Beyfortus was also authorised for children up to 24 months of age who can potentially get severe RSV disease during their second RSV season.
The drug is a single-dose long-acting antibody developed using AstraZeneca’s YTE technology.
The US health regulator gave its approval after the Antimicrobial Drugs Advisory Committee (AMDAC) unanimously voted in favour of Beyfortus’ favourable benefit-risk profile.
This decision was made considering the antibody’s extensive clinical development programme, which included three crucial late-stage clinical trials.
A single dose of Beyfortus showed sustained efficacy against RSV LRTD for five months across all clinical endpoints, AstraZeneca said.
Sanofi Vaccines EVP Thomas Triomphe said: “Today’s approval marks an unprecedented moment for protecting infant health in the US, following an RSV season that took a record toll on infants, their families, and the US healthcare system.
“Beyfortus is the only monoclonal antibody approved for passive immunisation to provide safe and effective protection for all infants during their first RSV season.”
AstraZeneca and Sanofi’s offering is said to be the first vaccine alternative that has been licenced to protect a wide range of infants. Its single dosage can be given either at birth or at the start of the RSV season.
Beyfortus showed a favourable safety profile that was constant across all clinical trials, and it was usually well tolerated.
The antibody and the placebo both had generally similar incidences of side effects, and most of them were mild to moderate in severity, the pharmaceutical major added.
AstraZeneca Vaccines and Immune Therapies EVP Iskra Reic said: “Beyfortus represents an opportunity for a paradigm shift in preventing serious respiratory disease due to RSV across a broad infant population in the US.
“The science that Beyfortus is built on demonstrates AstraZeneca’s continued leadership in addressing the needs of the most vulnerable populations and reducing the burden on healthcare systems.”
The product was also approved in European Union in October 2022 for the prevention of RSV LRTD in newborns and infants. It is currently under review in China, Japan and many other nations.