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Adverse event reporting can be found at the bottom of the page
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Click here for VYNDAQEL®▼ (tafamidis) Prescribing Information.
Efficacy was demonstrated in ATTR-ACT, a phase 3 multicentre, international, parallel design double-blind, placebo-controlled, randomised, 3-arm study in 441 patients with wild-type or hereditary ATTR-CM.1,2
The analysis compared the results of a pooled tafamidis (20 mg and 80 mg as meglumine) treatment group (n=264) with the placebo group (n=177).2
The licensed dose for VYNDAQEL in ATTR-CM is 61 mg once daily.1 VYNDAQEL 61 mg (tafamidis) corresponds to 80 mg tafamidis meglumine. Tafamidis and tafamidis meglumine are not interchangeable on a per mg basis. 20 mg dose is not licensed for ATTR-CM.1
Primary and secondary endpoints were met at 30 months.1,2
VYNDAQEL was superior to placebo in reducing the combination of all-cause mortality* and CV-related hospitalisations over 30 months (Win Ratio 1.70 [95% CI:1.26-2.29];p<0.001)2
6MWT=6-minute walk test; ARR=absolute risk reduction; ATTR-CM=transthyretin amyloid cardiomyopathy; CI=confidence interval; CV=cardiovascular; HR=hazard ratio; KCCQ-OS=Kansas City Cardiomyopathy Questionnaire Overall Summary; LS=least squares; NNT=number needed to treat; NYHA=New York Heart Association; RRR=relative risk reduction; SE=standard error; TTR=transthyretin.
References:
Explore the study of VYNDAQEL in ATTR-CM
See the safety profile of VYNDAQEL
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PP-UNP-GBR-7812. January 2024