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The Australian Prescription Medicine Decision Summary provides a short overview of the TGA's evaluation process leading to the registration of a new prescription medicine on the Australian Register of Therapeutic Goods (ARTG).
More in-depth information about the evaluation will be available in the Australian Public Assessment Report (AusPAR) for a particular prescription medicine, which can be found on the AusPAR search page once published.
Australian prescription medicine decision summary
|Submission type|| |
New biological entity
|Product name|| |
|Active ingredients|| |
|ATC codes|| |
|Date of decision|| |
15 January 2020
|Date of entry onto ARTG|| |
16 January 2020
|ARTG numbers|| |
|Black Triangle Scheme|| |
Yes. This product will remain in the scheme for 5 years, starting on the date the product is first supplied in Australia
Novartis Pharmaceuticals Australia Pty Ltd
|Sponsor address|| |
54 Waterloo Road, Macquarie Park NSW 2113
|Dose forms|| |
Solution for injection
|Other ingredients|| |
Sodium citrate, sucrose, polysorbate 80 and water for injections
Vial or prefilled syringe
|Pack sizes|| |
|Routes of administration|| |
Beovu must be administered by a qualified ophthalmologist experienced in administering intravitreal injections.
The recommended dose is 6 mg brolucizumab (0.05 mL solution) administered by intravitreal injection every 4 weeks (monthly) for the first 3 doses. Thereafter, the physician may individualise treatment intervals based on disease activity as assessed by visual acuity and/or anatomical parameters. A disease activity assessment is suggested 16 weeks (4 months) after treatment start. In patients with disease activity, treatment every 8 weeks (2 months) should be considered. In patients without disease activity, treatment up to every 12 weeks (3 months) should be considered. The physician may further individualise treatment intervals based on disease activity.
If visual and anatomical outcomes indicate that the patient is not benefiting from continued treatment, Beovu should be discontinued.
For further information refer to the Product Information.
|Pregnancy category|| |
Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.
The use of any medicine during pregnancy requires careful consideration of both risks and benefits by the treating health professional. This 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.
Beovu (brolucizumab (rbe)) was approved for the following therapeutic use:
Beovu is indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD).
Brolucizumab is a humanised monoclonal single-chain Fv (scFv) antibody fragment.
Increased levels of signalling through the vascular endothelial growth factor A (VEGF-A) pathway are associated with pathological ocular angiogenesis and retinal oedema in age-related macular degeneration. Brolucizumab binds with picomolar affinity to VEGF-A isoforms (for example, VEGF110, VEGF121, and VEGF165), thereby preventing binding of VEGF-A to its receptors VEGFR-1 and VEGFR-2. By inhibiting VEGF-A binding to its receptors, brolucizumab suppresses endothelial cell proliferation, thereby reducing pathological neovascularisation and decreasing vascular permeability.
The following table summarises the key steps and dates for this application.
|Submission dossier accepted and first round evaluation commenced||6 March 2019|
|First round evaluation completed||12 August 2019|
|Sponsor provides responses on questions raised in first round evaluation||12 September 2019|
|Second round evaluation completed||10 October 2019|
|Delegate's overall benefit-risk assessment and request for Advisory Committee advice||5 November 2019|
|Sponsor's pre-Advisory Committee response||19 November 2019|
|Advisory Committee meeting||6 December 2019|
|Registration decision (Outcome)||15 January 2020|
|Completion of administrative activities and registration on ARTG||16 January 2020|
|Number of working days from submission dossier acceptance to registration decision*||189|
*Statutory timeframe for standard applications is 255 working days
- Beovu brolucizumab (rbe) is to be included in the Black Triangle Scheme. The Product Information (PI) and Consumer Medicines Information (CMI) for Beovu 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 products.
- The brolucizumab European Union-Risk Management Plan (EU-RMP), version 1.2, dated 31 October 2019 (data lock point 23 April 2018), with Australian Specific Annex (ASA), version 2.0, dated 12 November 2019, included with submission PM-2019-00106-1-5, and any subsequent revisions, as agreed with the TGA will be implemented in Australia.
Any changes to which the sponsor has agreed should be included in a revised RMP and ASA. However, irrespective of whether or not they are included in the currently available version of the RMP document, the agreed changes become part of the risk management system.
An obligatory component of risk management plans is routine pharmacovigilance. Routine pharmacovigilance includes the submission of periodic safety update reports (PSURs).
Unless agreed separately between the supplier who is the recipient of the approval and the TGA, the first report must be submitted to TGA no later than 15 calendar months after the date of the approval letter. The subsequent reports must be submitted no less frequently than annually from the date of the first submitted report until the period covered by such reports is not less than three years from the date of this approval letter. The annual submission may be made up of two PSURs each covering six months. If the sponsor wishes, the six monthly reports may be submitted separately as they become available.
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.
- Batch release testing and compliance with Certified Product Details (CPD)
- All batches of Beovu brolucizumab imported into/manufactured in Australia must comply with the product details and specifications approved during evaluation and detailed in the Certified Product Details (CPD).
- Up to 5 initial batches of Beovu brolucizumab imported into/manufactured in Australia is not released for sale until samples and/or the manufacturer's release data have been assessed and endorsed for release by the TGA Laboratories Branch. Outcomes of laboratory testing are published biannually in the TGA Database of Laboratory Testing Results.
- The sponsor should be prepared to provide product samples, reference materials and documentary evidence as defined by the TGA Laboratories branch. The sponsor must contact Biochemistry.Testing@health.gov.au for specific material requirements related to the batch release testing/assessment of the product.
More information on TGA testing of biological medicines is available at Testing of biological medicines.
This batch release condition will be reviewed and may be modified on the basis of actual batch quality and consistency. This condition remains in place until the sponsor is notified in writing of any variation.