AstraZeneca and Sanofi’s Beyfortus (nirsevimab) has been approved in the US for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in newborns and infants born during or entering their first RSV season, the companies announced.

The US Food and Drug Administration’s (FDA) decision makes the long-acting antibody the first preventive option approved to protect a broad infant population, including those born healthy at term, preterm, or with specific health conditions that make them vulnerable to severe RSV disease.

The approval, which also applies to children aged up to 24 months who remain vulnerable to severe RSV disease through their second RSV season, was based on results from the Beyfortus clinical development programme spanning three pivotal late-stage clinical trials and follows a unanimous vote by the Antimicrobial Drugs Advisory Committee on the favourable benefit-risk profile of the drug.

Across all clinical endpoints, a single dose of Beyfortus demonstrated consistent efficacy against RSV LRTD extending through five months – the duration of a typical RSV season.

RSV is a common contagious virus characterised by several mild, cold-like symptoms. Although most people recover within a week or two, the virus can potentially cause severe illness in young infants, older adults and individuals with certain chronic medical conditions.

Each year in the US, an estimated 590,000 RSV disease cases in infants aged under one year require medical care, including physician office, urgent care, emergency room visits and hospitalisations.

Iskra Reic, executive vice president, vaccines and immune therapies, AstraZeneca, 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.”

Also commenting on the FDA’s decision, Thomas Triomphe, executive vice president, vaccines, Sanofi, said: “[The] 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 was approved by the European Commission in October last year for the same patient population, with regulatory applications currently under review in China, Japan and several other countries.

Reference：
https://www.pmlive.com/pharma_news/astrazenecasanofis_rsv_antibody_receives_fda_approval_for_use_in_infants_1494971