We will have limited operations from 15:00 Wednesday 24 December 2025 (AEDT) until Friday 2 January 2026. Find out how to contact us during the holiday period.
Beyfortus
Published
Product name
Beyfortus
Active ingredient
Nirsevimab
Submission type
New biological entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Beyfortus (nirsevimab) was approved for the following therapeutic use:
Beyfortus is indicated for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in:
- Neonates and infants born during or entering their first RSV season.
- Children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.
Beyfortus should be used in accordance with official recommendations.
How this medicine works
Nirsevimab is a medicine that helps protect against RSV infection. It is a type of antibody that sticks to the virus and stops it from entering cells. It has been changed slightly to last longer in the body. It works very well against both types of RSV. In tests on animals, it was able to completely stop the virus from spreading in the body when given just one day before infection.
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Beyfortus was considered favourable for the therapeutic use approved.
Sponsor