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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 studyVYNDAQEL significantly reduced the combination of all-cause mortality and CV-related hospitalizations vs placebo over 30 months, p=0.00061,2*Patients alive at month 30† Average CV-related hospitalizations per patient per year during 30 months
VYNDAQEL—the first and only treatment for patients with ATTR-CM to 
reduce all-cause mortality and CV-related hospitalization1 
See Long-term Survival Data 

Individual components—all-cause mortality
VYNDAQEL significantly reduced all-cause mortality vs placebo over 30 months1 

Individual component—all-cause mortality at month 301,2†‡§
~8 patients would need to be treated to prevent 1 death within 30 months 
(NNT=7.5)3 

Individual components—CV-related hospitalization
​​​​​​​
VYNDAQEL significantly reduced hospitalization vs placebo over 30 months1,2§

Individual component—CV-related hospitalization frequency during 30 months1,2‡§ ATTR-ACT study design Primary 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 
Analysis not adjusted for multiplicity.1 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.1 ATTR-ACT=Tafamidis in Transthyretin Cardiomyopathy Clinical Trial; ATTR-CM=transthyretin amyloid cardiomyopathy; Cl=confidence interval; CV=cardiovascular; HR=hazard ratio; LTE=long-term extension; NNT=number needed to treat.
Explore More ATTR-CM 5-year survival data See the Long-term Data ATTR-CM dosing Learn More
NEXT: ATTR-CM long-term survival 
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/NEJMoa1805689
VYNDAQEL Summary of Product CharacteristicsMaurer MS, Mann DL. The tafamidis drug development program: A translational triumph. JACC Basic Transl Sci. 2018;3(6):871-873.
VYNDAQEL Prescribing InformationLoading
Efficacy and Safety

Legal Category: S1A.Further information available upon request

PP-VYN-IRL-0181. September 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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