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Vyndamax and Vyndaqel

23 March 2020

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

Summary of submission

Submission type
New chemical entity
Product name
Vyndamax and Vyndaqel
Active ingredients
Tafamidis and tafamidis meglumine
ATC codes
N07XX08
Decision
Approved
Date of decision
13 March 2020
Date of entry onto ARTG
16 March 2020
ARTG numbers
314813, 316241
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
Sponsor
Pfizer Australia Pty Ltd
Sponsor address
Level 17, 151 Clarence Street, Sydney NSW 2000
Dose forms
Soft capsule
Strength

Vyndamax: 61 mg tafamidis

Vyndaqel: 20 mg tafamidis meglumine

Other ingredients

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

Containers
Blister pack
Pack sizes
30
Routes of administration
Oral
Dosage

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.

Pregnancy category

D

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.

What was approved?

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).

What is this medicine and how does it work?

What was the decision based on?

What steps were involved in the decision process?

What post-market commitments will the sponsor undertake?

  • 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.

Further information

The latest Product Information (PI) and Consumer Medicines Information (CMI) can be found at: ARTG search.

Australian Public Assessment Reports (AusPARs) can be found at: AusPAR search.

The latest news and updates regarding therapeutic goods regulation can be found at: TGA news room.