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Vyndamax and Vyndaqel
Published
Product name
Vyndamax and Vyndaqel
Active ingredient
Tafamidis and tafamidis meglumine
Submission type
New chemical entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
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).
How this medicine works
Tafamidis and tafamidis meglumine are selective stabilisers of transthyretin (TTR). Tafamidis and tafamidis meglumine bind with negative cooperativity to the two thyroxine binding sites on the native tetrameric form of TTR preventing dissociation into monomers, the rate-limiting step in the amyloidogenic process. The inhibition of TTR tetramer dissociation forms the rationale for the use of Vyndamax and Vyndaqel to reduce all-cause mortality and cardiovascular-related hospitalisation in transthyretin amyloid cardiomyopathy (ATTR-CM) patients. No studies have been undertaken to establish a direct relationship between this dissociation and an effect on reduction of amyloid deposition in the heart.
Why the TGA approved or did not approve this medicine
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 Vyndamax and Vyndaqel was considered favourable for the therapeutic use approved.
Sponsor