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A phase 3, multicentre, international, randomised, double-blind, placebo-controlled study, which evaluated the pooled tafamidis meglumine doses of 20 mg and 80 mg in 441 patients with wild-type or hereditary ATTR-CM1
Two-thirds of patients in the pooled tafamidis meglumine group were on the 80 mg dose.2
Approval of VYNDAMAX™ was based on ATTR-ACT, which evaluated the pooled tafamidis meglumine doses of 20 mg and 80 mg.3 A single VYNDAMAX™ 61 mg capsule is bioequivalent to tafamidis meglumine 80 mg (four 20-mg capsules) and is not interchangeable on a per-mg basis.4
¶Frequency of CV-related hospitalisations is used to compare patients who cannot be differentiated based on all-cause mortality.
ATTR-CM: transthyretin amyloid cardiomyopathy; CV: cardiovascular; eGFR: estimated glomerular filtration rate; LVAD: left ventricular assist device; mBMl: modified body mass index; MOA: mechanism of action; MOD: mechanism of disease; NYHA: New York Heart Association; NSAID: nonsteroidal anti-inflammatory drug; NT-proBNP: N-terminal pro-B-type natriuretic peptide; TTR: transthyretin.
MOH Approval No. : HF0098OA171/082022
Invalidation Date : 11/08/2024
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