AstraZeneca/Sanofi's RSV preventing therapy Beyfortus gets approval in Canada
BeritK

Health Canada approved AstraZeneca (NASDAQ:AZN) and Sanofi's (NASDAQ:SNY) antibody therapy Beyfortus to prevent respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in newborns and infants during their first RSV season.
The therapy was also approved for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.

Sanofi said that Beyfortus (nirsevimab) is the first and only single-dose immunization for preventing RSV disease in newborns and infants, including those born healthy, at term or preterm or with specific health conditions.
"Today is a historical day for RSV prevention as decades of research and development culminate in Canada's approval of the first immunization against RSV disease," said Jason Lee, head of Vaccines Medical Affairs, Sanofi Canada.
The approval was backed by data from three late-stage trials, including a phase 3 study called MELODY.
Sanofi aims to make o making Beyfortus available for the upcoming 2023/2024 RSV season.
Beyfortus was approved in the EU in November 2022, the first by a regulatory body for the therapy.