The FDA approved Vyndaqel (tafamidis meglumine) and Vyndamax (tafamidis) capsules for the treatment of cardiomyopathy (a form of heart disease) of wild type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults.
These are the first FDA-approved treatments for ATTR-CM.
Vyndaqel and Vyndamax have the same active ingredient, tafamidis, but cannot be substituted on a milligram to milligram basis because their recommended doses differ.
In studies after a period of 30 months, the survival rate was higher in the Vyndaqel group than in the placebo group and hospitalization rates were lower. Tafamidis may cause fetal harm in pregnancy.
Approvals were granted to FoldRx, a subsidiary of Pfizer.
