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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.

VYNDAQEL is the only approved treatment that specifically targets TTR destabilization—the cause of disease pathogenesis—and fortifies the TTR tetramer to preserve its natural function1-9

VYNDAQEL binds to TTR at the thyroxine-binding sites, stabilizing the tetramer and inhibiting amyloidosis-allowing TTR to circulate naturally through the bloodstream3,5,10

  • For patients with transthyretin amyloid cardiomyopathy (ATTR-CM), VYNDAQEL (tafamidis meglumine) provides powerful stabilization to prevent TTR tetramers from further dissociating into monomers, the rate-limiting step in the amyloidogenic process3-6,10
  • In clinical studies, VYNDAQEL (tafamidis meglumine) achieved TTR stabilization in 86% of patients with ATTR-CM11*
  • Over a 30-month clinical study, ATTR-CM patients using VYNDAQEL (tafamadis meglumine) 80 mg had a higher mean TTR concentration than those on VYNDAQEL (tafamidis meglumine) 20 mg or placebo12*
See the mechanism of action (MOA) of VYNDAQELA phase 3, multicenter, international, randomized, double-blind, placebo-controlled study, which evaluated pooled VYNDAQEL doses of 20 mg and 80 mg in 441 patients with wild-type or hereditary ATTR-CM.13ATTR-CM=transthyretin amyloid cardiomyopathy; TTR=transthyretin.
Explore More TTR is important to healthy function Learn the Role of TTR ATTR-CM dosing Learn More
References:Adams D, Cauquil C, Labeyrie C, Beaudonnet G, Algalarrondo V, Theaudin M. TTR kinetic stabilizers and TTR gene silencing: a new era in therapy for familial amyloidotic polyneuropathies. Expert Opin Pharmacother. 2016;17(6):791-802. doi:10.1517/14656566.2016.1145664Judge DP, Heitner SB, Falk RH, et al. Transthyretin stabilization by AG10 in symptomatic transthyretin amyloid cardiomyopathy. J Am Coll Cardiol. 2019;74(3):285-295. doi:10.1016/j.jacc.2019.03.012Sekijima Y. Transthyretin (ATTR) amyloidosis: clinical spectrum, molecular pathogenesis and disease-modifying treatments. J Neurol Neurosurg Psychiatry. 2015;86(9):1036-1043.Coelho T, Merlini G, Bulawa CE, et al. Mechanism of action and clinical application of tafamidis in hereditary transthyretin amyloidosis. Neurol Ther. 2016;5(1):1-25.Bulawa CE, Connelly S, DeVit M, et al. Tafamidis, a potent and selective transthyretin kinetic stabilizer that inhibits the amyloid cascade. Proc Natl Acad Sci USA. 2012;109(24):9629-9634.Clinical Study Report for Protocol PF-06291826. New York, NY: Pfizer Inc; August 2018.Monteiro C, Martins da Silva A, Ferreia N, et al. Cerebrospinal fluid and vitreous body exposure to orally administered tafamidis in hereditary ATTRV30M (p. TTRV50M) amyloidosis patients. Amyloid. 2018;25(2):120-128.Falk RH, Haddad M, Walker CR, Dorbala S, Cuddy SAM. Effect of tafamidis on serum transthyretin levels in non-trial patients with transthyretin amyloid cardiomyopathy. JACC CardioOncol. 2021;3(4):580-586. doi:10.1016/j.jaccao.2021.08.007 Coelho T, Maia LF, da Silva AM, et al. Tafamidis for transthyretin familial amyloid polyneuropathy: a randomized, controlled trial. Neurology. 2012;79(8):785-792.Maurer MS, Elliott P, Merlini G, et al. Design and rationale of the phase 3 ATTR-ACT clinical trial (tafamidis in transthyretin cardiomyopathy clinical trial). Circ Heart Fail. 2017;10(6):e003815. doi:10.1161 / NCT01994889. Available at: Accessed March 3, 2022.Damy T, Garcia-Pavia P, Hanna M, et al. Efficacy and safety of tafamidis doses in the Tafamidis in Transthyretin Cardiomyopathy Clinical Trial (ATTR-ACT) and long-term extension study. Eur J Heart. Published online October 18, 2020. doi:10.1002/ejhf.2027Maurer 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 Prescribing InformationLoading

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PP-VYN-IRL-0176. December 2022

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