This site is intended for U.S. healthcare professionals.

Visit Pfizer Medical

Menu

Close

Sign InLog Out
ProductsOrderMaterialsCo-pay Cards & Patient Savings OffersRequest SamplesHospital ProductsVaccinesPatient AssistancePfizer Oncology TogetherPfizer RxPathwaysExplore ContentEventsMaterialsVideosContact
Search

Menu

Close

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 VYNDAMAXVyndaLinkResourcesResourcesEventsMaterialsVideos
Prescribing InformationPatient InformationIndication Patient Site
Mortality and Hospitalization

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.1,2

*Also known as transthyretin amyloid cardiomyopathy (ATTR-CM).

 VYNDAMAX can help lower all-cause mortality and frequency of CV-related hospitalizations in both wild-type and hereditary ATTR cardiac amyloidosis1,3

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||

Of the 287 surviving patients at month 30

 VYNDAQEL significantly reduced the risk of mortality and frequency of CV-related hospitalizations vs placeboAll-cause mortality at month 301§||All-cause mortality at month 301§||
  • ~80% of total deaths were CV-related in both treatment groups1
  • ~80% of total deaths were CV-related in both treatment groups1
CV-related hospitalization frequency during 30 months3||CV-related hospitalization frequency during 30 months3||
  • Patient-years of treatment needed3: 4
    • ~4 patient-years of treatment needed to prevent 1 CV-related hospitalization
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 is the only treatment with a Class 1 recommendation for ATTR cardiac amyloidosis in the ACC/AHA/HFSA Guidelines5¶ 
Only VYNDAMAX is recommended by the ACC Expert Consensus Decision Pathway for patients with ATTR cardiac amyloidosis6¶ 

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

ContinueLoadingAs 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.2Primary analysis determined by the Finkelstein-Schoenfeld method, a hierarchical combination of both components, prioritizing all-cause mortality.1Heart transplantation, combined heart and liver transplantation, and cardiac mechanical assist device implantation are treated as equivalent to death in this analysis.1,3Individual components of the primary analysis.1As of November 2023, VYNDAMAX and VYNDAQEL are the only agents approved for ATTR cardiac amyloidosis recommended in the guidelines.ACC=American College of Cardiology; AHA=American Heart Association; ATTR=transthyretin amyloidosis; ATTR-ACT=Transthyretin Amyloidosis Cardiomyopathy Clinical Trial; CV=cardiovascular; HFSA=Heart Failure Society of America; NNT=number needed to treat.
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. Tafamidis treatment for patients with transthyretin amyloid cardiomyopathy. N Engl J Med. 2018;379(11):1007-1016.Data on file. Pfizer Inc., New York, NY.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):e876-e894. Kittleson MM, Ruberg FL, Ambardekar AV, et al. 2023 ACC expert consensus decision pathway on comprehensive multidisciplinary care for the patient with cardiac amyloidosis. J Am Coll Cardiol. 2023;81(11):1076-1126.
About VYNDAMAX A once-daily, oral treatment for wild-type or hereditary ATTR cardiac amyloidosisView VYNDAMAX dosingLoading

To report an adverse event, please call 1-800-438-1985

Pfizer for Professionals 1-800-505-4426

This site is intended only for U.S. healthcare professionals. The products discussed in this site may have different product labeling in different countries. The information provided is for educational purposes only.

© 2024 Pfizer Inc. All rights reserved.

PP-VDM-USA-1664
You are now leaving Pfizer You are now leaving a Pfizer operated website. Links to all outside sites are provided as a resource to our visitors. Pfizer accepts no responsibility for the content of sites that are not owned and operated by Pfizer.

PP-VDM-USA-0908
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.