21 Jul 2023 • The FDA approved Beyfortus (nirsevimab), a monoclonal antibody, for the prevention of respiratory syncytial virus(RSV) lower respiratory tract disease in newborns and infants. It is approved for use in neonates and infants born during or entering their first RSV season, as well as children up to 24 months old who are at risk of severe illness from the virus during their second RSV season.

The recommended dosage for infants varies based on their body weight. Trials of nirsevimab have shown promising results, with a single dose providing consistent protection of around 80% against medically attended RSV.

The safety and efficacy of Beyfortus were supported by three clinical trials (Trials 03, 04 and 05). The key measure of efficacy was the incidence of medically attended RSV lower respiratory tract infection, evaluated during the 150 days after Beyfortus administration

This approval is part of a series of recent regulatory decisions aimed at providing protection against RSV, a common respiratory infection that can cause severe illness in both young children and older adults.

Source: FDA | Read full story