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# 2 FoldRx NDAs Approved for Treating Heart Disease
- URL: https://www.fdaweb.com/2-foldrx-ndas-approved-for-treating-heart-disease/
- Published: 2019-05-06T12:00:00.000Z
- Updated: 2026-09-15T01:24:49.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144030

FDA has approved Pfizer subsidiary FoldRx’s NDAs for Vyndaqel (tafamidis meglumine) and Vyndamax (tafamidis) capsules for treating heart disease caused by transthyretin mediated amyloidosis (ATTR-CM) in adults. An [FDA release](https://www.fda.gov/news-events/press-announcements/fda-approves-new-treatments-heart-disease-caused-serious-rare-disease-transthyretin-mediated?ref=fdaweb.com) says these are the first FDA-approved treatments for ATTR-CM. “Vyndaqel and Vyndamax have the same active moiety, tafamidis, but they are not substitutable on a milligram to milligram basis and their recommended doses differ,” it says.

The agency says ATTR is caused by the buildup of amyloid in the body’s organs and tissues, interfering with their normal functioning. These protein deposits most frequently occur in the heart and peripheral nervous system. “Heart involvement can result in shortness of breath, fatigue, heart failure, loss of consciousness, abnormal heart rhythms and death,” it says. “Involvement of the peripheral nervous system can result in a loss of sensation, pain, or immobility in the arms, legs, hands and feet. Amyloid deposits can also affect the kidneys, eyes, gastrointestinal tract and central nervous system.”

Approvals were based on data from a clinical trial involving 441 patients randomized to receive Vyndaqel or a placebo. After about 30 months, the survival rate was higher in the Vyndaqel group than in the placebo group, FDA says, adding that it was also shown to reduce the number of hospitalizations for cardiovascular problems. It also notes that no drug-associated side effects have been identified.