This site contains promotional information intended only for healthcare professionals resident in the United Kingdom

Visit Pfizer Medical site

Menu

Close

Sign InLog Out
  • EN
Single LinkDropdownLabelLinkLinkLinkLinkLinked DropdownLabelLinkLinkLinkLinkMega MenuHeading

Example of description text sitting alongside header

LabelLinkLinkLinkLinkLabelLinkLinkLinkLinkLabelLinkLinkLinkLink
Linked Mega MenuHeading

Example of description text sitting alongside header

LabelLinkLinkLinkLinkLabelLinkLinkLinkLinkLabelLinkLinkLinkLink
EN - EnglishSelect a languageLanguagesEN - EnglishFR - Françias

Menu

Close

Sign InLog Out
  • EN
Single LinkDropdownLabelLinkLinkLinkLinkLinked DropdownLabelLinkLinkLinkLinkMega MenuHeading

Example of description text sitting alongside header

LabelLinkLinkLinkLinkLabelLinkLinkLinkLinkLabelLinkLinkLinkLink
Linked Mega MenuHeading

Example of description text sitting alongside header

LabelLinkLinkLinkLinkLabelLinkLinkLinkLinkLabelLinkLinkLinkLink
EN - EnglishSelect a languageLanguagesEN - EnglishFR - Françias
Search

Menu

Close

Sign In or RegisterLog Out
Pfizer MedicinesTherapy AreasExplore ContentEventsVideosMaterialsFeatured ArticlesLet’s ConnectSupplyAlliance HealthcareOff-contract claims

Adverse event reporting can be found at the bottom of the page

Menu

Close

Sign InLog Out
  • EN
Single LinkDropdownLabelLinkLinkLinkLinkLinked DropdownLabelLinkLinkLinkLinkMega MenuHeading

Example of description text sitting alongside header

LabelLinkLinkLinkLinkLabelLinkLinkLinkLinkLabelLinkLinkLinkLink
Linked Mega MenuHeading

Example of description text sitting alongside header

LabelLinkLinkLinkLinkLabelLinkLinkLinkLinkLabelLinkLinkLinkLink
EN - EnglishSelect a languageLanguagesEN - EnglishFR - Françias
About VYNDAQEL

Menu

Close

Sign InLog Out
  • EN
Single LinkDropdownLabelLinkLinkLinkLinkLinked DropdownLabelLinkLinkLinkLinkMega MenuHeading

Example of description text sitting alongside header

LabelLinkLinkLinkLinkLabelLinkLinkLinkLinkLabelLinkLinkLinkLink
Linked Mega MenuHeading

Example of description text sitting alongside header

LabelLinkLinkLinkLinkLabelLinkLinkLinkLinkLabelLinkLinkLinkLink
EN - EnglishSelect a languageLanguagesEN - EnglishFR - Françias
Study DesignEfficacySafety ProfileDosingReal-world evidenceSupporting Resources Supporting ResourcesGuidelines and ReimbursementLong Term Extension StudyModels of care MaterialsVideosContact us

Click here for VYNDAQEL®▼ (tafamidis) Prescribing Information. 

Vyndaqel Long Term Extension Study (LTE)Continuous treatment with tafamidis for 5 years significantly reduced all-cause mortality compared to starting on placebo in the LTE study, highlighting the need for early diagnosis and treatment in ATTR-CM1LTE Study Design 

 

Following completion of ATTR-ACT, patients were eligible to enrol in an open-label LTE study where they were able to switch from placebo to tafamidis, or continue treatment with tafamidis, for up to 60 months1

 

All-cause mortality was assessed in patients taking continuous tafamidis meglumine 80 mg to tafamidis free acid 61 mg vs. those initiated on placebo before transitioning to tafamidis meglumine 80 mg/20 mg and then to tafamidis 61 mg/day in the LTE1

 

The licensed dose for VYNDAQEL in ATTR-CM is 61 mg once daily. VYNDAQEL 61 mg (tafamidis) corresponds to 80 mg tafamidis meglumine. Tafamidis and tafamidis meglumine are not interchangeable on a per mg basis. Tafamidis meglumine 20 mg is not licensed in ATTR-CM.


*In addition to standard of care (e.g. diuretics)
Figure adapted from Elliot P, et al. Circ Heart Fail 2022; 15(1):e008193 and Damy T, et al. Eur J Heart Fail 2021;23(2): 277-85.
Study Results 
Baseline characteristics at month 30 of ATTR-ACT
At month 30 of ATTR-ACT, before enrolling in the LTE, patients treated with placebo had more severe disease than those treated with tafamidis meglumine 80 mg1

Figure adapted from Elliot P, et al. Circ Heart Fail 2022; 15(1):e008193 

Primary EndpointContinuous tafamidis treatment over 5 years reduced all-cause mortality1


There was a significant 41% risk reduction in all-cause mortality in patients receiving continuous tafamidis treatment compared with those first receiving placebo (p<0.001)1


A total of 82 placebo-treated patients continued in LTE, 54 of whom were randomised to receive tafamidis meglumine 80 mg/day and 28 of them were randomised to receive tafamidis meglumine 20 mg/day3

The licensed dose for VYNDAQEL in ATTR-CM is 61 mg once daily. VYNDAQEL 61 MG (tafamidis) corresponds to 80 mg tafamidis meglumine. Tafamidis and tafamidis meglumine are not interchangeable on a per mg basis. Tafamidis meglumine 20 mg is not licensed in ATTR-CM.

Figure adapted from Elliot P, et al. Circ Heart Fail 2022; 15(1):e008193

SafetyIn the LTE, 164 patients treated with tafamidis meglumine 80 mg/day transitioned to tafamidis free acid 61 mg/day1

Tafamadis was generally well tolerated in the LTE.

Frequency of AEs was generally similar or lower, in patients treated with tafamidis meglumine 80 mg/day who transitioned to tafamidis free acid 61 mg/day in the LTE vs. patients from the pooled tafamidis (tafamidis meglumine 80 mg/daily and tafamidis meglumine 20 mg/daily) or placebo arms in ATTR-ACT3,1

No new safety concerns emerged in patients treated with tafamidis meglumine 80 mg/day or tafamidis free acid 61 mg/day in the LTE1

  • Cumulative clinical data in ATTR-CM participants, as per SmPC:1
  • Common AEs (occurring in ≥1 to <10% of patients) include diarrhoea, rash and pruritus
Conclusion 
  • Tafamidis reduced the combination of all-cause mortality and cardiovascular-related hospitalisations compared with placebo over 30 months during ATTR-ACT3
  • Survival improved in patients who initially received placebo in ATTR-ACT once tafamidis treatment had been initiated during the LTE1
  • Patients receiving continuous tafamidis over 5 years showed a significant reduction in all-cause mortality compared with those who ­first received placebo, highlighting the importance of early diagnosis and treatment initiation in patients with ATTR-CM1
Explore more We have a team ready to support you with any queries.Get in touchLoadingAcronyms 
6MWT, 6-minute walk test; AE, adverse event; ATTR-ACT, Tafamidis in Transthyretin Cardiomyopathy Clinical Trial; ATTR-CM, transthyretin amyloid cardiomyopathy; CV, cardiovascular; HR, hazard ratio; KCCQ-OS, Kansas City Cardiomyopathy Questionnaire Overall Summary; LTE, long term extension; NT-proBNP, N-terminal pro-B-type natriuretic peptide; TTR, transthyretin.


References:

Elliott P, et al. Circ Heart Fail 2022;15(1):e008193.VYNDAQEL 61 mg (tafamidis) Summary of Product Characteristics.Maurer MS, et al. N Engl J Med 2018;379(11):1007–16.
PP-VYN-GBR-1940. March 2025
Download a summary of the ATTR-ACT/ LTE data here
Loading

Remind yourself of the key ATTR-ACT results

ATTR-ACT results Loading

Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk or search 

for MHRA Yellow Card in Google Play or Apple App Store

 

Adverse events should also be reported to Pfizer Medical Information on 01304 616161

PfizerPro Account

To access further materials, resources and receive communication about medicines and vaccines promoted by Pfizer.

Sign In or RegisterAccountSign Out

This site is intended only for healthcare professionals resident in the United Kingdom. If you are a member of the public wishing to access information on a specific medicine, please visit www.medicines.org.uk/emc

 

This website is brought to you by Pfizer Limited, a company registered in England 

and Wales under No. 526209 with its registered office at Ramsgate Road, Sandwich, Kent, CT13 9NJ

 

Copyright © 2025 Pfizer Limited. All rights reserved.

 

VAT registration number GB201048427

PP-UNP-GBR-11245. January 2025
You are now leaving PfizerPro​​​​​

You are now leaving www.pfizerpro.co.uk. Links to external websites are provided as a resource to the viewer. This website is neither owned or controlled by Pfizer Ltd. 

Pfizer accepts no responsibility for the content or services of the linked site.​​​​​​​​​​​​​​

​​​​​​​PP-PFE-GBR-3858. November 2021​​​​​​​
​​​​​​​
For UK Healthcare Professionals*

These pages are not intended for patients or for members of the general public. The healthcare professional web pages contain promotional content.

I confirm that I am a healthcare professional* resident in the United Kingdom.

If you select 'No', you will be redirected to Pfizer.co.uk where you will be able to access reference information on Pfizer's prescription medicines.

*The ABPI Code definition for healthcare professional is members of the medical, dental, pharmacy and nursing professionals and any other persons who in the course of their professional activities may administer, prescribe, purchase, recommend or supply a medicine.

PP-UNP-GBR-7812. January 2024.

YesNo
You are now leaving PfizerPro
​​​​​​​
​​​​​​​You are now leaving www.pfizerpro.co.uk. Links to external websites are provided as a resource to the viewer. This website is neither owned nor controlled by Pfizer Ltd. 

Pfizer accepts no responsibility for the content or services of the linked site other than the information or other materials relating to ​​​​​Pfizer medicines or 
business which it has provided or reviewed.

PP-PFE-GBR-3859. November 2021
​​​​​​​