US officials on Monday approved the first long-acting drug to protect infants and young children from the respiratory virus that sends tens of thousands of American children to the hospital each year.
RSV is a cold-like nuisance for most healthy people, but it can be life-threatening to the very young and very old.
The Food and Drug Administration has approved the injection for infants and children up to 2 years of age who are at increased risk of severe RSV infection.
“Today’s approval addresses the significant need for products to help reduce the impact of RSV disease on children, families, and the health care system,” said Dr. John Farley of the FDA in a statement.
Last year, an increase in cases of the respiratory syncytial virus flooded American hospitals with wheezing babies. There are no vaccines for children yet, although Pfizer and other companies are working on them.
AstraZeneca’s drug, which will be sold under the brand name Beyfortus, is a lab-grown version of the antibody that helps the immune system fight off RSV. Under FDA approval, babies — including premature babies — can receive a single injection to protect against the first season of RSV, which usually lasts about five months. Children up to the age of two can receive another dose to protect them during the second season against the virus.
Beyfortus, which will be marketed in the United States by Sanofi, is already approved in Canada, Europe and the United Kingdom. Sanofi did not immediately announce the price of the treatment in the United States.
FDA officials approved the drug based on three studies showing Bifortus reduced the risk of infection with RSV between 70% and 75% among infants and children 2 and under.
Centers for Disease Control and Prevention advisors will meet early next month to recommend exactly who should get the drug.
A similar antibody drug won FDA approval more than 20 years ago, but it’s only recommended for high-risk children and requires monthly injections. Pediatricians say the drug is underutilized and expect the long-term effect of the AstraZeneca dose to improve absorption.
In the United States, about 58,000 children under the age of 5 are hospitalized with RSV each year and several hundred die.
After decades of setbacks for respiratory syncytial virus research, drug companies made great strides this year, releasing the first vaccines against the virus. In May, the Food and Drug Administration approved two RSV vaccines for seniors from GlaxoSmithKline and Pfizer. In August, the US Food and Drug Administration is expected to make a decision on approving Pfizer’s vaccine for pregnant women, with the goal of providing protection to newborn babies.
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(tags to translation) COVID-19 (s) after (s) RSV