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About ATTR-CMAbout
ATTR-CM
Disease ImpactWhen to Rule Out ATTR-CMDiagnosing ATTR-CM
About VYNDAMAXAbout
VYNDAMAX
Mortality and Hospitalization6MWT/KCCQ-OS5-year DataHow VYNDAMAX WorksSafety Profile Study Design
DosingAccess & SupportAccess & SupportAccessing VYNDAMAXFree Trial ProgramResourcesResourcesEventsMaterialsVideos
Prescribing InformationPatient InformationIndication Patient Site
Mortality and HospitalizationStudy 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.3
VYNDAMAX improves survival and helps keep patients out of the hospital vs placebo1

Primary composite endpoint: VYNDAQEL significantly reduced the combination of all-cause mortality and CV-related hospitalizations vs placebo over 30 months, p=0.0006.1‡

Patients alive at month 301§|| Average CV-related hospitalizations per patient per year during 30 months1||Average CV-related hospitalizations per patient per year during 30 months1||​​​​​​

Averages below are from the 287 patients alive at month 30.

All-cause mortality as an individual component: VYNDAQEL significantly reduced the risk of all-cause mortality vs placebo, p=0.026 at month 30.1,2,4All-cause mortality at month 301,2,4§||All-cause mortality at month 301,2,4§||
  • ~80% of total deaths were CV-related in both treatment groups1
  • ~80% of total deaths were CV-related in both treatment groups1
CV-related hospitalizations as an individual component: VYNDAQEL significantly reduced the risk of frequency of CV-related hospitalizations vs placebo, p<0.0001 at month 30.1,2,4CV-related hospitalization frequency during 30 months1,2||CV-related hospitalization frequency during 30 months1,2||
  • ~4 patient-years of treatment are needed to prevent 1 CV-related hospitalization4
Study endpoints overview

Statistical analysis of individual components of the primary analysis overview1:


The components of the primary analysis, all-cause mortality and CV-related hospitalizations, were evaluated individually. All-cause mortality was analyzed with the use of a Cox proportional-hazards model, with treatment and the stratification factors treated as covariates. The CV-related hospitalization analysis was based on a Poisson regression model with treatment, transthyretin (TTR) status (hereditary and wild-type), New York Heart Association (NYHA) baseline class (NYHA classes I and II combined versus NYHA Class III), treatment-by-TTR genotype interaction, and treatment-by-NYHA baseline classification interaction terms as factors.​

VYNDAMAX has a Class 1 recommendation for ATTR cardiac amyloidosis in the AHA/ACC/HFSA Guidelines5
VYNDAMAX is recommended for ATTR cardiac amyloidosis in the ACC 2025 Concise Clinical Guidance6

Next: Impact on health-related quality of life and functional capacity

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Primary analysis determined by the Finkelstein-Schoenfeld method, a hierarchical combination of both components, prioritizing all-cause mortality.1,2§Heart transplantation, combined heart and liver transplantation, and cardiac mechanical assist device implantation are treated as equivalent to death in this analysis.1,2||Individual components of the primary analysis.1ACC=American College of Cardiology; AHA=American Heart Association; ATTR=transthyretin amyloidosis; ATTR-ACT=The Transthyretin Amyloidosis Cardiomyopathy Clinical Trial; CI=confidence interval; CV=cardiovascular; HFSA=Heart Failure Society of America; HR=hazard ratio; NNT=number needed to treat.
References:VYNDAQEL and VYNDAMAX [prescribing information]. New York, NY: Pfizer Inc; 2023.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.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, Mann DL. The tafamidis drug development program: a translational triumph. JACC Basic Transl Sci. 2018;3(6):871-873.Heidenreich PA, Bozkurt B, Aguilar D, et al. 2022 AHA/ACC/HFSA guideline for the management of heart failure: a report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2022;145(18):e895-e1032.Kittleson MM, Ambardekar AV, Cheng RK, et al. Transthyretin cardiac amyloidosis evaluation and management: 2025 ACC concise clinical guidance. J Am Coll Cardiol. Published online October 31, 2025. doi:10.1016/j.jacc.2025.09.004
About VYNDAMAX A once-daily, oral treatment for wild-type or hereditary ATTR cardiac amyloidosis1View VYNDAMAX dosingLoading

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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.