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VYNDAMAX helps people with transthyretin cardiac amyloidosis (ATTR-CM) live longer compared to placebo

  • VYNDAMAX* was studied in the “Tafamidis in Transthyretin Amyloidosis Cardiomyopathy Clinical Trial” (known as ATTR-ACT)
  • The study tested if VYNDAMAX could help people with ATTR-CM live longer and reduce hospitalizations due to heart problems
  • The study also tested the impact of VYNDAMAX on quality of life and ability to function

*The clinical studies of VYNDAQEL® tafamidis meglumine (a different form of tafamidis) supported the approval of VYNDAMAX. Both drugs contain the same active ingredient.

How was VYNDAMAX studied?

The safety and efficacy of VYNDAMAX were studied in a 30-month clinical study of 441 adult patients with wild-type or hereditary ATTR-CM.

  • The VYNDAMAX study primarily focused on the reduction of death and heart-related hospitalizations, as well as safety
  • VYNDAMAX was also assessed on other aspects of ATTR-CM, including walking distance (6-Minute Walk Test) and health-related quality of life
  • Efficacy and safety were determined by comparing patients treated with VYNDAMAX (n=264), with patients who did not take VYNDAMAX (placebo) (n=177)
  • Patients were evaluated every 6 months for a total of 30 months
VYNDAMAX was proven to help people live longer

 

Survival rate at month 30

Bar chart comparing survival rate for VYNDAMAX vs placebo in ATTR‑CM | Safety Info

AFTER 21/2YEARS

more people were alive taking VYNDAMAX than placebo

VYNDAMAX was proven to reduce hospitalizations for heart problems compared to placebo

 

  • In the study, patients taking VYNDAMAX had fewer heart-related hospitalizations than those in the placebo group

32% LOWER RISK
of hospitalizations related to heart problems

Icon representing reduced risk of heart related hospitalizations

Health-related quality-of-life measures†

In a 2.5-year clinical study, compared to those not on treatment (placebo group), people taking VYNDAMAX reported:

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Better quality of life

(mental health status, enjoyment of life)

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Fewer heart-related symptoms

(shortness of breath, fatigue, swollen feet or ankles)

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More comfort performing daily activities

(ability to perform social and physical activities)

†At the end of the 30-month study compared to people taking a placebo. The Kansas City Cardiomyopathy Questionnaire (KCCQ) was used to measure health-related quality of life. Patients in the VYNDAMAX and placebo groups had worse KCCQ overall summary scores at month 30 than at the start of the study.

Icon indicating important informationWhile there's no cure today, VYNDAMAX slows down ATTR-CM

 

Remember that even if you don’t feel it working, always take VYNDAMAX as prescribed. It’s important to tell your doctor how you are feeling.

 

Heart function and exercise capacity were measured in patients taking VYNDAMAX

The 6-Minute Walk Test (6MWT) measured heart function and exercise capacity.

At 30 months, people who took VYNDAMAX were able to walk a significant 83 yards farther (almost the length of a football field) on average than people who did not take VYNDAMAX (placebo).‡

Graphic showing a comparison of 6 minute walk distance, with people taking VYNDAMAX walking 83 yards farther than placebo| Safety Info‡Patients in the VYNDAMAX and placebo groups had worse 6-minute walking distance than at the start of the study.

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Jack Nicklaus seated indoors sharing his experience living with ATTR CM

"I want to be here for the legacy that matters most: my family."

Jack Nicklaus' signature

Jack Nicklaus,
— VYNDAMAX patient —
Golf Legend
Jack Nicklaus seated indoors sharing his experience living with ATTR CM

"I want to be here for the legacy that matters most: my family."

Jack Nicklaus' signature

Jack Nicklaus,
— VYNDAMAX patient —
Golf Legend
CARDIOLOGIST RECOMMENDED

VYNDAMAX is a treatment with a Class 1§ recommendation for ATTR-CM in guidelines from:

  • American College of Cardiology
  • American Heart Association
  • Heart Failure Society of America

§Class 1 guidelines are given when there’s strong evidence or general agreement that a treatment is beneficial, useful, and effective. The above recommendation is from the 2022 guidelines.

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