A preventive treatment for lower respiratory tract infections caused by RSV was approved by the European Commission on Friday, according to a company that makes it.
It is the first treatment of its kind to protect all babies in their first year of life.
A spokeswoman for drugmaker Sanofi says the study has also been submitted to the US Food and Drug Administration for approval. The company said it expects the treatment to be available in the United States by the 2023 – 2024 RSV season.
This year, RSV, or respiratory syncytial virus, has overwhelmed pediatric hospitals across the US. Almost all children get RSV before the age of 2, according to the US Centers for Disease Control and Prevention. Although it can often be a milder respiratory infection for many children and most adults, studies show that it is still the leading cause of hospitalization for all children.
Worldwide, in 2019 alone, there were more than 33 million cases and 3.6 million hospitalizations. There are an estimated 26,300 in-hospital deaths for children under five and 101,400 total deaths, according to a 2022 study published in the Lancet journal.
The new monoclonal antibody treatment is a joint project between AstraZeneca and Sanofi. It will be sold under the brand name Beyfortus (nirsevimab). Sanofi said it has been working on the project in collaboration with AstraZeneca for about five years.
The treatment is given to babies as a single dose when they are born or before the RSV season begins. And unlike a vaccine, where the body builds up its immunity over time in reaction to a vaccine, a monoclonal antibody works immediately. The most common side effects are rash, injection site reactions, and fever.
If accepted in the US, A single dose of Beyfortus would be the only option for RSV protection for the general pediatric population. Sanofi said broad coverage is important because 80 percent of children hospitalized for RSV do not have comorbidities.
Beyfortus RSV can also be used for a second season in children who remain highly vulnerable to RSV infection, usually in children with an underlying medical condition. conditions.
There is another monoclonal antibody treatment approved in the US and Europe called palivizumab or Synagis that protects against infections in high-risk children. With this treatment, children receive an intramuscular injection every month during the RSV season and usually need 5 doses. The treatment was approved in 1998.
Admission to Beyfortus Based on data from the European Commission study, the treatment reduced the incidence of RSV lower respiratory tract infections requiring medical attention by 70.1% compared with placebo in a phase 2b study, according to a Sanofi news release. In a phase 3 trial conducted in 21 different countries, Beyfortus reduced the incidence of RSV-associated bronchiolitis, inflammation of the small airways of the lungs, or pneumonia requiring medical attention by 74.5% compared to placebo.
“All the data we’ve generated across the population indicates that protection is around 80% among all children,” said Jon Heinrichs, global project leader for Sanofi Vaccines Research & Development. “We think it will make a big difference at RSV.”
RSV has also placed a heavy burden on doctors’ offices and hospitals, even outside of a bad RSV season like the one the US is seeing right now.
“Imagine a situation where 80% of that disease is preventable,” Heinrichs added.
For vulnerable children and mothers who refuse to get vaccinated, Dr. Helen Chu, an infectious disease specialist at the University of Washington, says Beyfortus could be a “game changer.”
Another advantage of such a treatment is that if the RSV season starts as early as this year, RSV hospitalizations rise to the levels normally seen in December, giving any child protection in time.
Beyfortus would directly protect the child. A vaccine given to the mother to provide passive protection to the child would not necessarily work for a child born after the end of the RSV season. By then, immunity would likely have been lost, Heinrichs said. Half of the children hospitalized with RSV are born outside the RSV season.
“So it’s very important in our minds to at least protect all children from RSV disease, and we think that’s the only way to do that,” Heinrichs said.
In the US, there are four new RSV vaccines that may be close to FDA review, and more than a dozen are currently undergoing testing. Most of these vaccines are for adults. A vaccine for children is further ahead, experts say.