FDA Approves New Drug to Protect Against RSV in Infants

MONDAY, July 17, 2023 (HealthDay Now) -- Parents now have a new long-acting drug to protect their children against respiratory syncytial virus (RSV), a common infection that hospitalizes as many as 3 percent of children younger than 1 year in the United States each year.

The U.S. Food and Drug Administration on Monday approved Beyfortus (nirsevimab-alip) for the prevention of RSV in newborns and infants born during or entering their first RSV season. The drug also is approved in children up to 2 years old who remain vulnerable to severe RSV disease through their second RSV season.

"RSV can cause serious disease in infants and some children and results in a large number of emergency department and physician office visits each year," John Farley, M.D., director of the Office of Infectious Diseases in the FDA Center for Drug Evaluation and Research, said in an agency news release. "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."

Beyfortus is a monoclonal antibody -- a laboratory-made protein that mimics immune system antibodies that target and fight RSV. A single injection of Beyfortus administered before or during RSV season can provide protection during the season, the FDA said.

The FDA cited three clinical trials that supported the safety and efficacy of Beyfortus in reducing the risk for RSV cases serious enough to require medical treatment.

One trial included 1,453 premature infants born during or entering their first RSV season. About 2.6 percent of infants treated with Beyfortus needed medical treatment for RSV versus 9.5 percent who received a placebo -- a risk reduction of about 70 percent. The second trial included 1,490 term and late preterm infants and showed a similar 75 percent risk reduction for Beyfortus compared with placebo. The third trial focused on children up to 24 months of age who remained vulnerable to severe RSV disease through their second RSV season because they had either chronic lung disease of prematurity or congenital heart disease. Again, the data supported the drug's use in children.

Approval of Beyfortus was granted to AstraZeneca.

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