Drug to help prevent serious RSV illness in babies approved by Health Canada
CBC
Health Canada has approved a new antibody drug to help protect babies from serious illness caused by respiratory syncytial virus, or RSV.
Nirsevimab, also known by its brand name Beyfortus, was authorized on April 19. It was developed by AstraZeneca and Sanofi.
Nirsevimab is "a monoclonal antibody to prevent serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) infection in newborns and infants during their first RSV season," Health Canada spokesman Mark Johnson said in an email to The Canadian Press on Friday.
The drug, which is given by injection, is also authorized for children up to two years of age if they are at risk of serious infection, he said.
Monoclonal antibodies are made in a laboratory to mimic natural antibodies to prevent or treat diseases.
Nirsevimab attaches to a protein on the surface of the virus and hinders its ability to enter the body's cells, especially those in the lungs, according to the European Medicines Agency, a regulatory body that last fall approved the drug for use in the European Union.
Canada already offers the monoclonal antibody palivizumab — also known by the brand name Synagis — to premature babies because they are more vulnerable to serious illness from RSV. The National Advisory Committee on Immunization (NACI) does not recommend palivizumab for healthy babies.
Palivizumab has to be injected about once a month — up to four times — during RSV season to remain effective. Nirsevimab requires only one dose that lasts the entire RSV season.
"It's a game-changer," said Dr. Anna Banerji, a pediatric infectious disease specialist at the University of Toronto's Dalla Lana School of Public Health.
Inuit babies in Nunavut are particularly hard-hit by RSV, Banerji said.
Many become seriously ill each year and have to be transported out of remote communities to hospitals in the south, she said.
A one-dose drug could prevent many of those cases from happening, Banerji said.
Although Health Canada has authorized nirsevimab for all infants, it's not known whether it will be that widely administered.
It's up to the provinces and territories to determine who gets the injections, often based on recommendations from the Canadian Agency for Drugs and Technologies in Health (CADTH).