Vabysmo
Registration timeline
The following table summarises the key steps and dates for this application.
This application was evaluated as part of the Australia-Canada-Singapore-Switzerland-United Kingdom (Access) New Active-Substance Work-Sharing Initiative (NASWSI), with work-sharing between the TGA, Health Canada, Health Sciences Authority Singapore, Swissmedic and the Medicines and Healthcare products Regulatory Authority (MHRA) of the United Kingdom. Each regulator made independent decisions regarding approval (market authorisation) of the new medicine.
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Description |
Date |
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Submission dossier accepted and first round evaluation commenced |
4 August 2021 |
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First round evaluation completed |
2 December 2021 |
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Sponsor provides responses on questions raised in first round evaluation |
28 January 2022 |
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Second round evaluation completed |
28 April 2022 |
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Delegate’s Overall benefit-risk assessment and request for Advisory Committee advice |
3 May 2022 |
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Sponsor’s pre-Advisory Committee response |
18 May 2022 |
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Advisory Committee meeting |
2 and 3 June 2022 |
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Registration decision (Outcome) |
4 August 2022 |
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Completion of administrative activities and registration on ARTG |
8 August 2022 |
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Number of working days from submission dossier acceptance to registration decision* |
188 |
*Statutory timeframe for standard applications is 255 working days
Acetic acid, histidine, methionine, polysorbate 20, sodium chloride, sucrose, and water for injections
Vabysmo must be administered by a qualified physician experienced in intravitreal injections. Each vial should only be used for the treatment of a single eye.
Neovascular (wet) age-related macular degeneration (nAMD)
The recommended dose for Vabysmo is 6 mg (0.05 mL) administered by intravitreal injection every 4 weeks for the first 4 doses. Thereafter, an assessment of disease activity based on anatomic and/or visual outcomes is recommended 20 to 24 weeks after treatment initiation so treatment can be individualised. Based on this assessment, in patients without disease activity, administration of Vabysmo every 16 weeks should be considered. Based on this assessment, in patients with disease activity, treatment every 8 weeks or 12 weeks should be considered (see Section 5.1 of the Product Information).
Diabetic macular oedema (DMO)
The recommended dose for Vabysmo is 6 mg (0.05 mL) administered by intravitreal injection every 4 weeks for the first 4 doses. Thereafter, treatment may be individualised using a treat and extend approach following an assessment of the individual patient's anatomic and/or visual outcomes. Following the outcome of this assessment, the dosing interval may remain at every 4 weeks, or may be extended in 4 week increments every 16 weeks. If anatomic or visual outcomes change, the treatment interval should be adjusted accordingly (see Section 5.1 of the Product Information).
Continued monitoring of disease activity and individualisation of dosing is recommended. Monitoring between the dosing visits should be scheduled based on the patient's status and at the physician's clinical judgement.
Duration of treatment
Vabysmo is intended for long-term treatment. The duration of treatment for DMO is adjusted accordingly to clinical response. The duration of treatment for nAMD is likely to be long-term treatment.
If visual and/or anatomic outcomes indicate that the patient is not benefitting from continued treatment, Vabysmo should be discontinued.
For further information regarding dosage, refer to the Product Information.
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.
Vabysmo (faricimab) was approved for the following therapeutic use:
Vabysmo is indicated for the treatment of:
- Neovascular (wet) age-related macular degeneration (nAMD)
- Diabetic macular oedema (DMO).
Angiopoietin-2 (Ang-2) causes vascular instability by promoting endothelial destabilisation, pericyte loss, and pathological angiogenesis, thus potentiating vascular leakage and inflammation. It also sensitises blood vessels to the activity of VEGF-A resulting in further vascular destabilisation. Ang-2 and VEGF-A synergistically increase vascular permeability and stimulate neovascularisation.
By dual inhibition of Ang-2 and VEGF-A, faricimab reduces vascular permeability and inflammation, inhibits pathological angiogenesis and restores vascular stability.
- Vabysmo (faricimab) is to be included in the Black Triangle Scheme. The PI [Product Information] and CMI [Consumer Medicines Information] for Vabysmo 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 Vabysmo EU [European Union]-risk management plan (RMP) (version 1.1, dated 4 March 2022, data lock point 31 October 2021), with Australia specific annex (version 1.2, dated 30 March 2022), included with Submission PM-2021-02671-1-5, to be revised to the satisfaction of the TGA, 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).
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 the 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.
If the product is approved in the EU during the three years period, reports can be provided in line with the published list of EU reference dates 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 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 (revision 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.
- The final clinical study reports (CSR) for Study GR40306 [TENAYA trial] and Study GR40844 [LUCERNE trial] should be submitted to the TGA, once available.
- For all injectable products the Product Information must be included with the product as a package insert.