Beyfortus
Authorised
This medicine is authorised for use in the European Union
nirsevimab
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Beyfortus is a medicine used to prevent serious lower respiratory tract (lung) disease caused by respiratory syncytial virus (RSV) in newborns and children during their first RSV season.
Beyfortus contains the active substance nirsevimab.
The medicine can only be obtained with a prescription.
Beyfortus is given as a single injection into the thigh muscle. It is given once before the RSV season starts or at birth for infants born during the RSV season. The recommended dose is 50 mg for children weighing less than 5 kg and 100 mg for children weighing 5 kg or more.
For more information about using Beyfortus, see the package leaflet or contact your healthcare provider.
The active substance in Beyfortus, nirsevimab, is a monoclonal antibody. A monoclonal antibody is a type of protein that has been designed to recognise and attach to a specific structure (called an antigen). Nirsevimab attaches to a protein called ‘F protein’ on the surface of RSV. When nirsevimab is attached to this protein, the virus becomes unable to enter the body’s cells, especially those in the lungs. This helps to prevent RSV infection.
Beyfortus was shown to be effective at reducing lower respiratory tract disease caused by RSV in three main studies.
One study compared Beyfortus with placebo (a dummy treatment) in 1,490 healthy children born prematurely and at term (at 35 weeks gestation or more). After receiving Beyfortus during their first RSV season, 1.2% of children (12 out of 994) developed RSV-induced lung disease that required medical attention compared with 5%1 (25 out of 496) in the placebo group.
Similar results were seen in a second study comparing Beyfortus with placebo in 1,453 children born five or more weeks prematurely (between 29 and 35 weeks gestation). After receiving Beyfortus during their first RSV season, 2.6% of children (25 out of 969) developed RSV-induced lung disease that required medical attention compared with 9.5% (46 out of 484) in the placebo group.
A third study compared Beyfortus with palivizumab (another medicine to prevent RSV-induced lung disease) in children who were either born prematurely, or born at full term but had heart or lung disease which put them at risk of RSV-induced lung disease. After receiving Beyfortus, 4 children (out of 616) developed RSV-induced lung disease that required medical attention compared with 3 children (out of 309) in the group who had palivizumab.
1Correction of percentage in section “what benefits of Beyfortus have been shown in studies?”: 2.6% has been amended to 5% (25 out of 496)
The most common side effects with Beyfortus (which may affect up to 1 in 100 people) are rash occurring within 14 days after injection, and fever and injection site reactions occurring within 7 days after injection.
For the full list of side effects and restrictions with Beyfortus, see the package leaflet.
Beyfortus was shown to be effective at preventing RSV-induced lung disease that required medical attention. In terms of safety, its side effects are considered manageable and in line with what can be expected of this class of medicines. The European Medicines Agency decided that Beyfortus’s benefits are greater than its risks and it can be authorised for use in the EU.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Beyfortus have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Beyfortus are continuously monitored. Suspected side effects reported with Beyfortus are carefully evaluated and any necessary action taken to protect patients.
Beyfortus received a marketing authorisation valid throughout the EU on 31 October 2022.
Product information
Latest procedure affecting product information:
II/0024
05/09/2024
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Beyfortus
- Active substance
- nirsevimab
- International non-proprietary name (INN) or common name
- nirsevimab
- Anatomical therapeutic chemical (ATC) code
- J06BD08
Pharmacotherapeutic group
Immune sera and immunoglobulinsTherapeutic indication
Beyfortus is indicated for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in:
i. Neonates and infants during their first RSV season.
ii. Children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season (see section 5.1).
Beyfortus should be used in accordance with official recommendations.
Beyfortus is indicated for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in:
i. Neonates and infants during their first RSV season.
ii. Children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season (see section 5.1).
Beyfortus should be used in accordance with official recommendations.
News on Beyfortus
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