The FDA approved the first antibody designed to give babies protection against respiratory syncytial virus during their first year of life.
Beyfortus, known as nirsevimab and developed by Sanofi and AstraZeneca, is a single injection of antibodies against the RSV virus. In late-stage clinical trials, the shot reduced the number of doctors' visits as a result of RSV by 70 percent in infants born at term and prematurely. The FDA also cleared the antibody for children up to 24 months who are at risk of developing severe disease.
Immune protection from Beyfortus lasts about five months. It is not a vaccine because it doesn't cause babies to generate their own immune response.
Typically, the RSV season occurs in the fall and winter months, and leads to as many as 80,000 pediatric hospital visits and as many as 300 deaths annually, according to the CDC.
In the U.S., there was no protection for the majority of infants against RSV until now. Synagis, an antibody made by the company Sobi, is only for infants at risk of developing severe illness due to the virus. It also must be given every four weeks. The FDA is also reviewing an RSV vaccine for pregnant individuals who could pass on immunity to their babies, and the agency is slated to make a decision next month.
"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," John Farley, director of the Office of Infectious Diseases in the FDA's Center for Drug Evaluation and Research, said in a statement.
The European Commission approved Beyfortus last year. Sanofi and AstraZeneca estimate that they will be prepared to distribute shots ahead of the 2023-2024 RSV season. The companies have not yet disclosed a price for the treatment.
