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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.

In a pre-specified exploratory and sensitivity subgroup analysis from ATTR-ACT1 VYNDAQEL showed similar reductions in wild-type and hereditary ATTR-CM subgroups1*

Reduced risk of all-cause mortality, despite poorer prognosis in hereditary ATTR-CM1

 See data

Disease subtypes

NYHA class

All-cause mortality in patients with wild-type and hereditary ATTR-CM1†‡​​​​​​​

Post hoc subgroup analysis of ATTR-ACT and LTE study2

Continuous treatment with VYNDAQEL 80 mg to 61 mg§ showed similar results in wild-type and hereditary ATTR-CM subgroups2

Reduced risk of all-cause mortality vs patients initiated on placebo who later transitioned to VYNDAQEL2||

Wild-type

Hereditary

Post hoc subgroup analysis of ATTR-ACT and LTE study2

Continuous treatment with VYNDAQEL 80 mg/61 mg§ showed greater survival in patients with ATTR-CM with baseline NYHA classes I, II, or III2

Reduced risk of all-cause mortality vs patients initiated on placebo who later transitioned to VYNDAQEL2||

Baseline NYHA class I/II

Baseline NYHA class III

ATTR-ACT study designIn pre-specified exploratory and sensitivity analysis from ATTR-ACT (Tafamidis in Transthyretin Cardiomyopathy Clinical Trial), baseline characteristics, all-cause mortality, and change from baseline to month 30 in 6-minute walk test (6MWT) distance, and Kansas City Cardiomyopathy Questionnaire-Overall Summary (KCCQ-0S) score were compared in patients with wild-type and hereditary ATTR-CM. In all patients, all-cause mortality and frequency of all-cause hospitalization (assessed by Finkelstein-Schoenfeld method) were lower with VYNDAQEL than placebo (win ratio 1.45 [95% Cl: 1.10 to 1.93]; p=0.0088).1 Although this was a pre-specified exploratory and sensitivity analysis, no formal hypothesis testing was performed for the analysis given that the endpoint of all-cause mortality was met in the primary analysis. Therefore, no conclusion can be drawn from the pre-specified analysis.1,3 p-values for these analyses were not adjusted for multiplicity.1A single VYNDAQEL (tafamidis) 61-mg capsule corresponds to VYNDAQEL (tafamidis meglumine) 80 mg (four 20-mg capsules) and is not interchangeable on a per-mg basis.4,5 All-cause mortality was assessed by Cox proportional hazards model by genotype (wtATTR and hATTR) and by NYHA baseline classification (NYHA class I or II and NYHA class Ill) subgroups.2
Median follow-up in the wild-type ATTR-CM subgroup was 58.3 months in patients who received continuous VYNDAQEL and 57.5 months in patients who started on placebo and later transitioned to VYNDAQEL.2 
Median follow-up in the hereditary ATTR-CM subgroup was 58.9 months in patients who received continuous VYNDAQEL and 50.1 months in patients who started on placebo and later transitioned to VYNDAQEL.2
Median follow-up in NYHA class I/II was 58.5 months in patients who received continuous VYNDAQEL and 57.4 months in patients who started on placebo and later transitioned to VYNDAQEL.2Median follow-up in NYHA class Ill was 57.8 months in patients who received continuous VYNDAQEL and 55.8 months in patients who started on placebo and later transitioned to VYNDAQEL.2 ​​​​​​​Not statistically significant.ATTR-ACT=Tafamidis in Transthyretin Cardiomyopathy Clinical Trial; ATTR-CM=transthyretin amyloid cardiomyopathy; Cl=confidence interval; HR=hazard ratio; LTE=long-term extension; NYHA=New York Heart Association.
Explore More ATTR-CM dosing Learn More VYNDAQEL specifically targets TTR destabilization View VYNDAQEL Mechanism of Action
NEXT: ATTR-CM key secondary endpoints
References:Rapezzi C, Elliott P, Damy T, et al. Efficacy of tafamidis in patients with hereditary and wild-type transthyretin amyloid cardiomyopathy: further analyses from ATTR-ACT. JGC Heart Fail. 2021;9(2):115-123. doi:10.1016/j.jchf.2020.09.011
Elliott P, Drachman BM, Gottlieb SS, et al. Long-term survival with tafamidis in patients with transthyretin amyloid cardiomyopathy. Circ Heart Fail. 2022;153e008193:1-8. 
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/NEJMoa1805689
VYNDAQEL Summary of Product Characteristics.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. doi:10.1002/cpdd.789.
VYNDAQEL Prescribing InformationLoading
Efficacy and Safety Profile

Legal Category: S1A.Further information available upon request

PP-VYN-IRL-0181. December 2022

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