WASHINGTON (AP) – US officials on Monday approved the first long-acting drug to protect babies and toddlers against a respiratory virus that sends thousands of American children to the hospital each year.
RSV a nuisance that looks like a cold to most healthy people, but can be life-threatening in the young and the elderly.
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 serious RSV.
“Today’s approval addresses the critical 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.
AstraZeneca’s drug, sold under the brand name Beyfortus, is a laboratory version of an antibody that helps the immune system fight RSV. Under FDA approval, children—including premature infants—can receive a single injection to protect against their first RSV season, which usually lasts about five months. Children up to 2 years of age can receive another dose to protect them during their second season of exposure to the virus.
Beyfortus, which will be marketed in the US by Sanofi, is already approved in Canada, Europe and Sanofi of the United Kingdom did not immediately announce the price of the US treatment.
FDA officials approved the drug based on three studies that showed Beyfortus reduced the risk of RSV infection by 70% to 75% among infants and children 2 and younger.
Advisers to the Centers for Disease Control and Prevention 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 is only recommended for high-risk children and requires monthly injections. Pediatricians say the drug is underused and hope the long-term effect of AstraZeneca’s shot will improve acceptance.
In the United States, about 58,000 children younger than 5 are hospitalized for RSV each year and hundreds die.
After decades of RSV research falters, drugmakers have made a major breakthrough this year, launching the first vaccines against the virus. In May, the FDA approved two RSV vaccines for older adults from GlaxoSmithKline and Pfizer. In August, the FDA is expected to make a decision on approval Pfizer vaccine for pregnant womenin order to protect their newborn children.
The Associated Press Health and Science Section is supported by the Howard Hughes Medical Institute Science and Media Education Group. The AP is solely responsible for all matters.