The Food and Drug Administration approved Monday a drug aimed at protecting infants and toddlers from respiratory syncytial virus, or RSV.
The monoclonal antibody from Sanofi and AstraZeneca, called Beyfortus, is the first of its kind likely to be widely available to everyone up to 24 months of age beyond a small population of immunocompromised children.
“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,” said Dr. John Farley, director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research. Monday’s “approval addresses the great need for product to help reduce the impact of RSV disease on children, families and the health care system.”
The new drug prevents RSV lower respiratory tract disease in infants and children entering or during their first RSV season and is the second monoclonal antibody on the market. The other option – palivizumab – is only recommended for high-risk infants who were born severely premature at 29 weeks or earlier.
FDA officials approved the drug based on three studies showing Beyfortus reduced the risk of RSV infection between 70% and 75% among infants and children 2 and younger. Although the drug is not a vaccine, it is meant to prevent severe illness like a vaccine.
Beyfortus, which will be marketed in the U.S. by Sanofi, is already approved in Canada, Europe, and the U.K. Sanofi did not immediately announce the U.S. price of the treatment.
The FDA approved the world’s first RSV vaccine, GSK’s Arexvy, in May to protect adults 60 and older from the worst consequences of the respiratory disease.
Another RSV vaccine by Pfizer is awaiting final approval from the regulatory agency and would be used in pregnancy to help prevent severe disease in infants during their first six months of life.
In the U.S., about 58,000 children younger than 5 are hospitalized for RSV each year and several hundred die.
Contributing: Associated Press. Follow Adrianna Rodriguez on Twitter: @AdriannaUSAT.
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