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    Efficacy and Safety Profile

    Approval of VYNDAMAX was based on ATTR-ACT, a phase 3, multicenter, international, randomized, double-blind, placebo-controlled study, which evaluated pooled VYNDAQEL® (tafamidis meglumine) doses of 20 mg and 80 mg in 441 patients with wild-type or hereditary ATTR-CM—a single VYNDAMAX 61-mg capsule is bioequivalent* to VYNDAQEL 80 mg (four 20-mg capsules) and is not interchangeable on a per-mg basis.

    Primary analysis

    Individual components of the primary analysis

    Key secondary endpoints

    Safety profile

    VYNDAQEL® (tafamidis meglumine) significantly reduced the combination of all-cause mortality and CV-related hospitalizations vs placebo over 30 months, p=0.0006

    Primary analysis determined by the Finkelstein-Schoenfeld method, a hierarchical combination of both components, prioritizing all-cause mortality

    ** This is an optional area where footnotes can live.

        *As determined by the predefined 90% confidence interval criteria of 80%-125% bioequivalence limits for tafamidis area under curve (AUC) and peak plasma concentration (Cmax) after repeated oral daily dosing for 7 days.​​

        †Heart transplantation, combined heart and liver transplantation, and cardiac mechanical assist device implantation are treated as equivalent to death in this analysis.​​​​​​​

    Next: Individual components of the primary analysis

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    References:
    1. Tankisheva E. A phase 1, open-label, randomized, crossover, multiple dose, pivotal bioequivalence study to compare PF-06291826 4 × 20 mg tafamidis meglumine and 61 mg: tafamidis free acid soft gelatin capsules administered under fasted conditions to healthy volunteers. Full Clinical Study Report [protocol B3461056]. July 23, 2018.

    2. Maurer MS, Schwartz JH, Gundapaneni B, et al. Tafamidis treatment for patients with transthyretin amyloid cardiomyopathy. N Engl J Med. 2018;379(11):1007-1016.

    A once-daily, oral treatment for wild-type or hereditary ATTR-CM

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    Safety and Efficacy and ATTR-CM resources for you and your patients

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    VYNDAMAX® AND VYNDAQEL® are registered trademarks of Pfizer Inc.

    Adverse Reactions

    In studies in patients with ATTR-CM, the frequency of adverse events in patients treated with VYNDAQEL® (tafamidis meglumine) was similar to placebo.

    Specific Populations

    Pregnancy: Based on findings from animal studies, VYNDAQEL and VYNDAMAX may cause fetal harm when administered to a pregnant woman.

    Lactation: There are no available data on the presence of tafamidis in human milk, the effect on the breastfed infant, or the effect on milk production. Tafamidis is present in rat milk. When a drug is present in animal milk, it is likely the drug will be present in human milk. Breastfeeding is not recommended during treatment with VYNDAQEL and VYNDAMAX.

    VYNDAQEL and VYNDAMAX are indicated for the treatment of the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis in adults to reduce cardiovascular mortality and cardiovascular-related hospitalization.
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    Please see Full Prescribing Information including Patient Information.

      INDICATION AND LIMITATIONS OF USE

      VYNDAQEL and VYNDAMAX are indicated for the treatment of the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis in adults to reduce cardiovascular mortality and cardiovascular-related hospitalization.
      ​​​​​​​
      Please see Full Prescribing Information including Patient Information.