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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

▼ 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.

Post hoc analysis of ATTR-ACT and LTE study' Patients taking continuous VYNDAQEL 80 mg/61 mg* showed a clinically significant improvement in survival at 5 years compared to those first treated with placebo1†‡Time to all-cause mortality in ATTR-ACT and LTE1​​​​​​​
53% preliminary 5-year survival rate in patients taking continuous VYNDAQEL (tafamidis meglumine) 80 mg to VYNDAQEL (tafamidis) 61 mg 
vs 32% in patients who first received placebo (p<0.001)1 
LTE study design A single VYNDAQEL 61-mg capsule corresponds to VYNDAQEL 80 mg (four 20-mg capsules) and is not interchangeable on a per-mg basis.2,3Upon completion of ATTR-ACT, patients could enroll in the ongoing LTE post hoc analysis for up to 60 months. In the LTE study, patients treated with VYNDAQEL 80 mg in ATTR-ACT continued with VYNDAQEL 80 mg, then transitioned to VYNDAQEL 61 mg and were compared with those treated with placebo in ATTR-ACT, who were randomized to VYNDAQEL 80 mg or VYNDAQEL 20 mg (2:1), then transitioned to VYNDAQEL 61 mg. Median LTE follow-up was 58.5 months in the continuous 80 mg to 61 mg VYNDAQEL group and 57.1 months in the placebo to 80 mg/20 mg to 61 mg group. For both groups, time zero for survival analyses was the time of enrollment in ATTR-ACT.1The primary efficacy outcome in the LTE study was all-cause mortality, with heart transplant and implantation of a cardiac mechanical assist device treated as death. Differential all-cause mortality in the 2 groups was assessed by Cox proportional hazards model with treatment, genotype, and NYHA baseline classification in the model.1ATTR-ACT=Tafamidis in Transthyretin Cardiomyopathy Clinical Trial; ATTR-CM=transthyretin amyloid cardiomyopathy; Cl=confidence interval; HR=hazard ratio; LTE=long-term extension. 
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References: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. 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
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Efficacy and Safety Profile

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PP-VYN-IRL-0181. December 2022

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