Vyndamax and Vyndaqel
Registration timeline
The following table summarises the key steps and dates for these applications.
These applications were evaluated as part of the Australia-Canada-Singapore-Switzerland (ACSS) Consortium, with work-sharing between TGA and Health Sciences Authority Singapore. Each regulator made independent decisions regarding approval (market authorisation) of the new medicines.
| Description | Date |
|---|---|
| Positive Designation (Orphan) | 23 January 2019 |
| Submission dossier accepted and first round evaluation commenced | 11 April 2019 |
| First round evaluation completed | 3 September 2019 |
| Sponsor provides responses on questions raised in first round evaluation | 1 November 2019 |
| Second round evaluation completed | 6 December 2019 |
| Delegate's overall benefit-risk assessment and request for Advisory Committee advice | 7 January 2020 |
| Sponsor's pre-Advisory Committee response | 21 January 2020 |
| Advisory Committee meeting | (Early ACM advice: 1 to 2 August 2019) 7 February 2020 |
| Registration decision (Outcome) | 13 March 2020 |
| Completion of administrative activities and registration on ARTG | 16 March 2020 |
| Number of working days from submission dossier acceptance to registration decision* | 187 |
*Statutory timeframe for standard applications is 255 working days
Vyndamax
Macrogol 400, Polysorbate 20, Povidone, Butylated hydroxytoluene
Gelatin shell (117781): Gelatin, Glycerol, Iron oxide red, Partially dehydrated liquid sorbitol, Sorbitol, Mannitol
Opacode WB water based monogramming ink NSP-78-18022 White (PI 3883): Ethanol, Isopropyl alcohol, Macrogol 400, Polyvinyl acetate phthalate, Propylene glycol, Titanium dioxide, Strong ammonium solution
Vyndaqel
Macrogol 400, Polysorbate 80, Sorbitan mono-oleate
Gelatin shell (116678): Gelatin, Glycerol, Iron oxide yellow, Partially dehydrated liquid sorbitol, Sorbitol, Mannitol, Titanium dioxide
Opacode Purple S-1-10011-N (PI 3413): Ethanol, Isopropyl alcohol, Macrogol 400, Polyvinyl acetate phthalate, Propylene glycol, Carmine, Brilliant Blue FCF, Strong ammonium solution
Treatment should be initiated and remain under the supervision of a physician knowledgeable in the management of patients with transthyretin amyloid cardiomyopathy (ATTR-CM).
Vyndamax
The recommended dose of Vyndamax is 61 mg tafamidis orally once daily (see Section 5.1 Pharmacodynamic properties).
A single 61 mg Vyndamax (tafamidis) capsule is bioequivalent to 80 mg Vyndaqel (tafamidis meglumine) (administered as four 20 mg Vyndaqel capsules) and is not interchangeable on a per mg basis (see Section 5.1 Pharmacodynamic properties and Section 5.2 Pharmacokinetic properties).
No dose ranging studies have been undertaken.
Vyndaqel
The recommended dose of Vyndaqel is 80 mg tafamidis meglumine (administered as four 20 mg capsules) once daily.
A dose of 80 mg Vyndaqel (tafamidis meglumine) (administered as four 20 mg Vyndaqel capsules) is bioequivalent to a single 61 mg Vyndamax (tafamidis) capsule and is not interchangeable on a per mg basis (see Section 5.1 Pharmacodynamic properties and Section 5.2 Pharmacokinetic properties).
No dose ranging studies have been undertaken.
For further information refer to the Product Information.
Vyndamax (tafamidis) and Vyndaqel (tafamidis meglumine) was approved for the following therapeutic use:
Vyndamax/Vyndaqel is indicated for the treatment of adult patients with wildtype or hereditary transthyretin amyloid cardiomyopathy (ATTR-CM).
- Vyndamax (tafamidis) and Vyndaqel (tafamidis meglumine) are to be included in the Black Triangle Scheme. The Product Information (PI) and Consumer Medicines Information (CMI) for Vyndamax and Vyndaqel 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 Vyndaqel EU-Risk Management Plan (RMP) (version 9.1, dated 31 July 2019, data lock point 1 August 2018), with Australian specific Annex (version 1.1, dated 17 October 2019), included with submission PM-2019-01399-1-3, and any subsequent revisions, as agreed with the TGA will be implemented in Australia.
The Vyndamax EU-RMP (version 9.1, dated 31 July 2019, data lock point 1 August 2018), with Australian specific Annex (version 1.1, dated 17 October 2019), included with submission PM-2019-00391-1-3, 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.