FDA approves new drug to protect babies from RSV
CBSN
The Food and Drug Administration announced Monday it had approved a new kind of immunization to protect babies from RSV, or respiratory syncytial virus. The drug, nirsevimab, is one of two new options doctors hope could soon prevent the leading cause of hospitalization facing American infants.
Outside advisers to the federal government have previously hailed nirsevimab's showing in clinical trials as potentially "groundbreaking" for protecting babies. A panel of the FDA's outside experts voted in June to back the drug's safety and efficacy.
"Today's approval addresses the great need for products to help reduce the impact of RSV disease on children, families and the health care system," the FDA's Dr. John Farley, director of the Office of Infectious Diseases in the FDA's Center for Drug Evaluation and Research, said in a statement.
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