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Device/Product name
Beyfortus
Active Ingredient
Nirsevimab
Date of decision
Published
Submission type
New biological entity
Decision
Approved
What was the decision based on
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.
What steps were involved in the decision process

Registration timeline

The following table summarises the key steps and dates for this application.

Description

Date

Submission dossier accepted and first round evaluation commenced

 

30 November 2022

 

Delegate’s Overall benefit-risk assessment and request for Advisory Committee advice

6 September 2023

 

Advisory Committee meeting

5 and 6 October 2023

 

Registration decision (Outcome)

22 November 2023

 

Completion of administrative activities and registration on ARTG

24 November 2023

 

Number of working days from submission dossier acceptance to registration decision*

200

 

*Statutory timeframe for standard applications is 255 working days

Date of entry onto ARTG
Black triangle scheme
Yes
Dose forms
Solution for injection
Strength
50 mg/0.5 mL and 100 mg/ 1 mL
Containers
Prefilled syringe
Pack sizes
1 and 5
Routes of administration
Intramuscular
Dosage

Neonates and infants: first respiratory syncytial virus (RSV) season

For neonates and infants born during or entering the RSV season, administer Beyfortus starting from birth. For infants born outside the RSV season, administer Beyfortus once prior to the start of the RSV season considering duration of protection provided by Beyfortus (see Section 5.1 of the Product Information).

The recommended dosage of Beyfortus for neonates and infants born during or entering their first RSV season is based on body weight and is administered as a single intramuscular injection.

There are limited data available in extremely preterm infants (Gestational Age (GA) <29 weeks) less than 8 weeks of age (see Section 4.8, 5.1 and 5.2 of the Product Information). No clinical data are available in infants with a postmenstrual age (gestational age at birth plus chronological age) of less than 32 weeks. 

Children who remain at increased risk for severe RSV disease: second RSV season

For children up to 24 months of chronological age who remain at increased risk for severe RSV disease in their second RSV season, the recommended dosage of Beyfortus is a single 200 mg dose administered as two intramuscular injections (2 x 100 mg) at the same visit.

Children undergoing cardiac surgery with cardiopulmonary bypass

For children undergoing cardiac surgery with cardiopulmonary bypass, an additional dose of Beyfortus is recommended as soon as the child is stable after surgery to ensure adequate nirsevimab serum levels.

The safety and efficacy of nirsevimab in children aged 2 to 18 years have not been established. No data are available. Limited data or no data are available in infants with a range of underlying conditions.

For further information refer to the Product Information.

Pregnancy category
B2

Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed.

Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage.

The use of any medicine during pregnancy requires careful consideration of both risks and benefits by the treating health professional. The pregnancy database must not be used as the sole basis of decision making in the use of medicines during pregnancy. The TGA does not provide advice on the use of medicines in pregnancy for specific cases. More information is available from obstetric drug information services in your state or territory.
What was approved

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.

What is this medicine and how does it work
Nirsevimab is a recombinant neutralising human immunoglobulin G1 kappa (IgG1κ) long-acting monoclonal antibody to the prefusion conformation of the RSV F protein which has been modified with a triple amino acid substitution (YTE) in the Fc region to extend serum half-life. Nirsevimab binds to a highly conserved epitope in antigenic site Ø on the prefusion protein with dissociation constants (KD) = 0.12 nM and KD = 1.22 nM for RSV subtype A and B strains, respectively. Nirsevimab inhibits the essential membrane fusion step in the viral entry process, neutralising the virus and blocking cell-to-cell fusion.

The potential for rapid protection was evaluated in a cotton rat model of RSV infection using a non-YTE version of nirsevimab (IG7). Intramuscular administration one day prior to inoculation with RSV A or B provided complete protection from viral replication in the upper and lower respiratory tracts.
What post-market commitments will the sponsor undertake
  • Beyfortus (nirsevimab) is to be included in the Black Triangle Scheme. The PI [Product Information] and CMI [Consumer Medicines Information] for Beyfortus must include the black triangle symbol and mandatory accompanying text for five years, which starts from the date that the sponsor notifies the TGA of supply of the product.
  • The Beyfortus EU [European Union]-risk management plan (RMP) (version 2 succession 1, dated 23 March 2023, data lock point 9 November 2022), with Australia-specific annex (version 1 succession 2, dated 13 July 2023), included with Submission PM-2022-04428-1-2, and any subsequent revisions, as agreed with the TGA will be implemented in Australia.
    • An obligatory component of risk management plans is routine pharmacovigilance. Routine pharmacovigilance includes the submission of periodic safety update reports (PSURs).
    • Reports are to be provided in line with the current published list of EU reference dates and frequency of submission of PSURs until the period covered by such reports is not less than three years from the date of the approval letter.
    • The reports are to at least meet the requirements for PSURs as described in the European Medicines Agency’s Guideline on Good Pharmacovigilance Practices (GVP) Module VII-periodic safety update report (Rev 1), Part VII.B Structures and processes. Note that submission of a PSUR does not constitute an application to vary the registration. Each report must have been prepared within ninety calendar days of the data lock point for that report.
  • Laboratory Testing and Compliance with Certified Product Details (CPD)
  1. All batches of Beyfortus supplied in Australia must comply with the product details and specifications approved during evaluation and detailed in the Certified Product Details (CPD).
  2. When requested by the TGA, the sponsor should be prepared to provide product samples, specified reference materials and documentary evidence to enable the TGA to conduct laboratory testing on the Product. Outcomes of laboratory testing are published biannually in the TGA Database of Laboratory Testing Results and periodically in testing reports on the TGA website.
  • Certified Product Details
    • The Certified Product Details (CPD), as described in Guidance 7: Certified Product Details of the Australian Regulatory Guidelines for Prescription Medicines (ARGPM), in PDF format, for the above products should be provided upon registration of these therapeutic goods. In addition, an updated CPD should be provided when changes to finished product specifications and test methods are approved in a Category 3 application or notified through a self-assessable change.
    • A template for preparation of CPD for biological prescription medicines can be obtained from the TGA website [for the form] [for the CPD guidance]
    • The CPD should be emailed to Biochemistry.Testing@tga.gov.au as a single PDF document.

Further information

The latest Product Information (PI) and Consumer Medicines Information (CMI) can be found by searching the Australian Register of Therapeutic Goods (ARTG).

Australian Public Assessment Reports (AusPARs) can be found by searching our AusPAR dataset.

The latest news and updates regarding therapeutic goods regulation can be found on our news page.

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