U.S. officials on Monday approved the first long-acting drug to protect babies and young children against respiratory syncytial virus, or RSV.

 

RSV sends tens of thousands of American children to the hospital each year. The virus is a cold-like disease for most healthy people. But it can be life-threatening in the very young and very old. Last year, a large increase in RSV cases crowded U.S. hospitals with sick children.

 

The Food and Drug Administration (FDA) approved the injection for infants and children up to 2 years old who face increased risk of severe RSV.

 

The approval helps “reduce the impact of RSV disease on children, families and the health care system” said FDA's Dr. John Farley in a statement.

 

The drugmaker AstraZeneca developed the drug. It will be sold under the name Beyfortus. It is a laboratory-made version of an antibody that helps the immune system fight off RSV.

 

Under the FDA approval, babies — including small infants — can receive a single injection to protect against their first season of RSV, which usually lasts about five months. Children up to age 2 can receive another dose to protect them during their second season facing the virus.

 

Beyfortus is already approved in Canada, Europe and Britain. It did not immediately announce the U.S. price of the treatment.

 

FDA officials approved the drug based on three studies. They showed Beyfortus reduced the risk of RSV infection between 70 percent and 75 percent 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 the drug is only recommended for high-risk babies and requires monthly injections. Doctors say that drug is underused. But they expect the longer-lasting effect of AstraZeneca's shot to be more popular.

 

In the U.S., about 58,000 children younger than 5 are hospitalized for RSV each year. Several hundred die.

 

After years of setbacks for RSV research, drugmakers have made big improvements this year. 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 approving Pfizer’s vaccine for pregnant women. The aim is for the vaccine to pass along protection to their newborns.

 

 

Words in This Story

infant — n. a very young child

antibody — n. a substance produced by the body to fight disease

dose — n. the amount of a medicine, drug, or vitamin that is taken at one time