Beyfortus, a drug to prevent severe RSV in children, gets FDA approval

The United States Food and Drug Administration (FDA) on Monday approved a new preventive treatment to defend infants and children from the common and sometimes dangerous respiratory syncytial virus (RSV). The injectable drug, called Beyfortus (nirsevimab-alip), is designed for all children entering their first RSV season and for children up to 2 years old who remain vulnerable to severe RSV disease during their second RSV season.

RSV can cause serious illness in infants and some children and results in a large number of visits to emergency rooms and doctors’ offices each year, said John Farley, MD, MPH, director of the Office of Infectious Diseases at the FDA’s Center for Drug Evaluation and Research, in a statement.

The Centers for Disease Control and Prevention (CDC) estimates that RSV hospitalizes 58,000 to 80,000 children under 5 each year. RSV is the leading cause of hospitalization for infants under 1 year of age in the United States, averaging 16 times the annual rate for influenza.

Although RSV typically causes mild, cold-like symptoms in most infants and young children, some develop lower respiratory tract illnesses such as pneumonia and bronchiolitis (swelling of the small airways in the lungs). Premature infants and those with chronic lung disease or significant congenital heart disease are at the highest risk for RSV.

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