AstraZeneca and Sanofi’s Beyfortus (nirsevimab) was approved in the US to prevent respiratory syncytial virus (RSV) lower respiratory tract disease.
The approval includes newborns and infants born during or entering their first RSV season and children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season. Beyfortus will be available in the US ahead of the upcoming 2023-2024 RSV season from fall to the end of spring.
AstraZeneca shares were down slightly on Monday The UK drug company with administrative and logistics operations in northern Delaware has seen a pullback in its stock price after what investors viewed as disappointing results from drug development trials.
The approval by the Food and Drug Administration follows the unanimous vote by the Antimicrobial Drugs Advisory Committee (AMDAC) on the favorable benefit-risk profile of Beyfortus, and was based on the clinical development program for Beyfortus spanning three late-stage clinical trials. Across all clinical endpoints, a single dose of Beyfortus demonstrated consistent efficacy against RSV, extending through five months, the duration of a typical RSV season.
Beyfortus is the first preventive option approved to protect a broad infant population, including those born healthy at term or preterm or with specific health conditions that make them vulnerable to severe RSV disease. The single dose can be administered at the beginning of the RSV season or at birth for those born during the RSV season.
Iskra Reic, executive vice president, vaccines and immune therapies at 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. 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.”
RSV is the leading cause of hospitalization for infants under the age of one in the US, averaging 16 times higher than the annual rate for influenza.5,6 Each year, an estimated 590,000 RSV disease cases in infants under one require medical care, including physician office, urgent care, emergency room visits, and hospitalizations. The most common adverse events were rash and injection site reactions.
Beyfortus was approved in the European Union in October 2022 for the prevention of RSV LRTD in newborns and infants during their first RSV season.
