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Valerie DeBenedette is managing editor of Drug Topics.
Two different versions of tafamadis get the FDA’s nod to treat a rare heart disease.
The FDA has approved Vyndaqel (tafamidis meglumine) and Vyndamax (tafamidis) capsules for treatment of cardiomyopathy caused by transthyretin mediated amyloidosis (ATTR-CM) in adults. ATTR-CM is rare, but is debilitating and can be fatal. Both drugs are from FoldRx, a division of Pfizer.
Tafamidis is the first treatment approved for ATTR-CM.
The efficacy of Vyndaqel and Vyndamax in treating ATTR-CM was shown in a clinical trial of 441 patients randomized to receive Vyndaqel or a placebo. The survival rate was higher in the Vyndaqel group than in the placebo group after about 30 months. Vyndaqel was also shown to reduce the number of hospitalizations for cardiovascular problems.
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The recommended dosages of the two drugs are different. The recommended dose of Vyndaqel is 80 mg once daily, taken as four 20-mg capsules, while the recommended dose for Vyndamax is 61 mg once-daily, taken as a single capsule. Vyndamax was developed as a more convenient form of Vindaqel, according to a statement by Pfizer.
About 100,000 people in the United States currently live with ATTR-CM. It is caused by the buildup of amyloid protein in the heart and can result in shortness of breath, fatigue, heart failure, loss of consciousness, abnormal heart rhythms, and death. Amyloid deposits can also affect the kidneys, eyes, gastrointestinal tract, and central nervous system.
Tafamidis may cause fetal harm when administered to pregnant women. Women of childbearing age should discuss pregnancy planning and prevention with their healthcare professional before taking either Vyndaqel or Vyndamax.
Pfizer has set a list price for Vyndaqel at $225,000 for a year’s treatment, according to Reuters.