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AboutAbout ATTR-CMUrgencySuspectDetectDiagnostic flowchartAbout ATTR-PNUrgencyAwarenessPartnershipStudy DesignStudy DesignAbout ATTR-PNUrgencyAwarenessPartnershipEfficacy & SafetyPivotal efficacyLong-term survivalSubgroup analysisKey secondary endpointsEarly efficacy measuresSafety profileATTR-PNPivotal efficacyPivotal efficacy ALTLong-term efficacyMutations efficacyLong-term survivalSafety profileDosingATTR-CM dosingATTR-PNPivotal efficacyPivotal efficacy ALTLong-term efficacyMutations efficacyLong-term survivalSafety profileMOD/MOARole of TTRATTR-CM MODATTR-CM MOAATTR-PNATTR-PN MODATTR-PN MOASupport & ResourcesMaterialsVideosATTR-PNATTR-PN MODATTR-PN MOA

Vyndaqel 61mg is indicated for the treatment of wild‑type or hereditary transthyretin amyloidosis in adult patients with cardiomyopathy
(ATTR-CM).1

▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. Refer to section 4.8 of the SmPC for how to report adverse reactions.

ATTR-ACT phase 3 study1 As early as 6 months, VYNDAQEL significantly reduced the decline in functional capacity and quality of life for patients1,2

Reduction in functional capacity decline demonstrated in change to 6-minute walk test (6MWT) and Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ-OS)​​​​​​​† 

6MWT change

KCCQ-OS score change

Patients with no change or improved KCCQ-0S score, change from baseline to month 302,3‡§||​​​​​​​
41.8% of patients on VYNDAQEL reported no change or improved KCCQ-0S ​​​​​​​scores from baseline to month 30 vs 21.4% of patients on placebo2,3
ATTR-ACT study designThe 6-minute walk test (6MWT) evaluates patients' functional capacity by measuring their distance walked in 6 minutes.1
The Kansas City Cardiomyopathy Questionnaire-Overall Summary (KCCQ-OS) score assesses patients' quality of life using the following domains: total symptoms (symptom frequency, symptom burden), physical limitation, quality of life, and social limitation. Scores range from 0 to 100, with higher scores reflecting better health status. Vital status at month 30 was assessed for all enrolled patients.3No change=score change of O; lmproved=score change 1-59. The KCCQ-0S assesses patient health status and quality of life through 4 domains: quality of life (eg, enjoyment of life), social limitations, physical limitations, and total symptoms of HF.1-3This chart does not include patients who had a score of -1 to -80. The total number of patients with a score of -80 to 59 is 170 for VYNDAQEL and 84 for placebo.221.2% of VYNDAQEL-treated patients experienced no change or an improvement between 0-9 points, vs 11.9% of patients on placebo. 17.1% of VYNDAQEL-treated patients experienced an improvement between 10-29 points, vs 8.3% of patients on placebo. 3.5% of VYNDAQEL-treated patients experienced an improvement between 30-59 points, vs 1.2% of patients on placebo.2
ATTR-CM=transthyretin amyloid cardiomyopathy; LS=least-squares; SE=standard error.
Explore More ATTR-CM dosing Learn More VYNDAQEL specifically targets TTR destabilization View VYNDAQEL Mechanism of Action
NEXT: ATTR-CM early efficacy measures
​​​​​​​References: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. doi:10.1056/NEJMoa1805689Clinical Study Report for Protocol B3461028. New York, NY: Pfizer Inc.; August 2018.Hanna M, Damy T, Grogan M, et al. Impact of tafamidis on health-related quality of life in patients with transthyretin amyloid cardiomyopathy (from the Tafamidis in Transthyretin Cardiomyopathy Clinical Trial). Am J Cardiol. 2021;141:98-105. doi:10.1016/j.amjcard.2020.10.066
VYNDAQEL Prescribing InformationLoading
Efficacy and Safety Profile

Legal Category: S1A.Further information available upon request

PP-VYN-IRL-0181. December 2022

Adverse events should be reported. Report an adverse event to your national reporting system (HPRA Pharmacovigilance)
 

Adverse events should also be reported to Pfizer Medical Information on 1800 633 363

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