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About ATTR-CMAbout
ATTR-CMDisease ImpactWhen to Rule Out ATTR-CMDiagnosing ATTR-CMAbout VYNDAMAXAbout
VYNDAMAXMortality and Hospitalization6MWT/KCCQ-OS5-year DataHow VYNDAMAX WorksSafety Profile Study DesignDosingAccess & SupportAccess & SupportAccessing VYNDAMAXFree Trial ProgramResourcesResourcesEventsMaterialsVideos
Prescribing InformationPatient InformationIndication Patient Site
6MWT and KCCQ-OSStudy design

Approval of VYNDAMAX was based on ATTR-ACT, a phase 3, multicenter, international, randomized, double-blind, placebo-controlled study, which evaluated pooled VYNDAQEL® (tafamidis meglumine) doses of 20 mg and 80 mg in 441 patients with wild-type or hereditary transthyretin cardiac amyloidosis*—a single VYNDAMAX 61-mg capsule is bioequivalent† to VYNDAQEL 80 mg (four 20-mg capsules) and is not interchangeable on a per-mg basis.1-3

Also known as transthyretin amyloid cardiomyopathy (ATTR-CM).As determined by the predefined 90% confidence interval criteria of 80% to 125% bioequivalence limits for tafamidis area under curve (AUC) and peak plasma concentration (Cmax) after repeated oral daily dosing for 7 days.2ATTR-ACTVYNDAMAX demonstrated benefits in functional capacity and health-related quality of life vs placebo16MWT

The 6MWT evaluates patients’ functional capacity by measuring the distance walked in 6 minutes. LS mean (SE) change in distance walked on the 6MWT from baseline to month 30 was a predefined secondary endpoint of ATTR-ACT (pooled VYNDAQEL, n=264; placebo, n=177; p<0.0001). Total distances walked on the 6MWT (pooled VYNDAQEL, 296 m; pooled placebo, 222 m).1,3
 

KCCQ-OS

The KCCQ-OS score assesses patient health status using the following domains: total symptoms (symptom frequency, symptom burden), physical limitation, QoL, and social limitation. LS mean (SE) change from baseline to month 30 in the KCCQ-OS score was a predefined secondary endpoint of ATTR-ACT. KCCQ-OS scores range from 0 to 100, with lower scores denoting poorer QoL. Total KCCQ-OS scores (pooled VYNDAQEL -7; pooled placebo -21).1,3

Key secondary endpoint overview: The treatment effect of tafamidis on functional capacity and health status was assessed by the 6MWT and KCCQ-OS score, respectively. Both key secondary endpoints evaluated change from baseline to month 30.3

Next: 5-year data ContinueLoading6MWT=6-minute walk test; ATTR-ACT=The Transthyretin Amyloidosis Cardiomyopathy Clinical Trial; KCCQ-OS=Kansas City Cardiomyopathy Questionnaire-Overall Summary; LS=least squares; QoL=quality of life; SE=standard error.
References: VYNDAQEL and VYNDAMAX [prescribing information]. New York, NY: Pfizer Inc; 2023.Lockwood PA, Le VH, O’Gorman MT, et al. The bioequivalence of tafamidis 61-mg free acid capsules and tafamidis meglumine 4 x 20-mg capsules in healthy volunteers. Clin Pharmacol Drug Dev. 2020;9(7):849-854.Maurer MS, Schwartz JH, Gundapaneni B, et al; ATTR-ACT Study Investigators. Tafamidis treatment for patients with transthyretin amyloid cardiomyopathy. N Engl J Med. 2018;379(11):1007-1016. Spertus JA, Jones PG, Sandhu AT, Arnold SV. Interpreting the Kansas City Cardiomyopathy Questionnaire in clinical trials and clinical care: JACC state-of-the-art review. J Am Coll Cardiol. 2020;76(20):2379-2390. Elliott P, Drachman BM, Gottlieb SS, et al. Long-term survival with tafamidis in patients with transthyretin amyloid cardiomyopathy. Circ Heart Fail. 2022;15(1):e008193.Data on file. Pfizer Inc., New York, NY.
About VYNDAMAXVYNDAMAX has been studied long-term1,5,6 
See the 5-year data
LoadingVYNDAQEL safety was similar to placebo1 See safety dataLoading

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INDICATION AND LIMITATIONS OF USE VYNDAQEL and VYNDAMAX are indicated for the treatment of the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis in adults to reduce cardiovascular mortality and cardiovascular-related hospitalization.Please see Full Prescribing Information including Patient Information.
Important Safety InformationAdverse Reactions
In studies in patients with ATTR-CM, the frequency of adverse events in patients treated with VYNDAQEL® (tafamidis meglumine) was similar to placebo.

Specific Populations

Pregnancy: Based on findings from animal studies, VYNDAQEL and VYNDAMAX may cause fetal harm when administered to a pregnant woman.

Lactation: There are no available data on the presence of tafamidis in human milk, the effect on the breastfed infant, or the effect on milk production. Tafamidis is present in rat milk. When a drug is present in animal milk, it is likely the drug will be present in human milk. Breastfeeding is not recommended during treatment with VYNDAQEL and VYNDAMAX.IndicationVYNDAQEL® (tafamidis meglumine) and VYNDAMAX are indicated for the treatment of the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis in adults to reduce cardiovascular mortality and cardiovascular-related hospitalization.

Please see Full Prescribing Information including Patient Information.