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The disease is caused by the buildup of abnormal deposits of amyloid in the body’s organs and tissues, interfering with normal function, and most often occurs in the heart and nervous system. Symptoms associated with amyloid buildup in the heart include shortness of breath, fatigue, heart failure, loss of consciousness, abnormal heart rhythms, and death.
FDA approval of both drugs was based on results of a clinical trial in which 441 patients with transthyretin-mediated amyloidosis received either tafamidis meglumine or placebo. After a mean of 30 months, patients who received tafamidis meglumine had a higher survival rate and a lower number of cardiovascular-related hospitalizations than did patients in the placebo group.
No drug-associated side effects have yet been identified; however, tafamidis can cause fetal harm when administered to a pregnant woman.
“Transthyretin-mediated amyloidosis is a rare, debilitating, and often fatal disease. The treatments we’re approving today are an important advancement in the treatment of the cardiomyopathy caused by transthyretin-mediated amyloidosis,” said Norman Stockbridge, MD, PhD, director of the Division of Cardiovascular and Renal Drugs in the FDA’s Center for Drug Evaluation and Research.
Find the full press release on the FDA website.
The disease is caused by the buildup of abnormal deposits of amyloid in the body’s organs and tissues, interfering with normal function, and most often occurs in the heart and nervous system. Symptoms associated with amyloid buildup in the heart include shortness of breath, fatigue, heart failure, loss of consciousness, abnormal heart rhythms, and death.
FDA approval of both drugs was based on results of a clinical trial in which 441 patients with transthyretin-mediated amyloidosis received either tafamidis meglumine or placebo. After a mean of 30 months, patients who received tafamidis meglumine had a higher survival rate and a lower number of cardiovascular-related hospitalizations than did patients in the placebo group.
No drug-associated side effects have yet been identified; however, tafamidis can cause fetal harm when administered to a pregnant woman.
“Transthyretin-mediated amyloidosis is a rare, debilitating, and often fatal disease. The treatments we’re approving today are an important advancement in the treatment of the cardiomyopathy caused by transthyretin-mediated amyloidosis,” said Norman Stockbridge, MD, PhD, director of the Division of Cardiovascular and Renal Drugs in the FDA’s Center for Drug Evaluation and Research.
Find the full press release on the FDA website.
The disease is caused by the buildup of abnormal deposits of amyloid in the body’s organs and tissues, interfering with normal function, and most often occurs in the heart and nervous system. Symptoms associated with amyloid buildup in the heart include shortness of breath, fatigue, heart failure, loss of consciousness, abnormal heart rhythms, and death.
FDA approval of both drugs was based on results of a clinical trial in which 441 patients with transthyretin-mediated amyloidosis received either tafamidis meglumine or placebo. After a mean of 30 months, patients who received tafamidis meglumine had a higher survival rate and a lower number of cardiovascular-related hospitalizations than did patients in the placebo group.
No drug-associated side effects have yet been identified; however, tafamidis can cause fetal harm when administered to a pregnant woman.
“Transthyretin-mediated amyloidosis is a rare, debilitating, and often fatal disease. The treatments we’re approving today are an important advancement in the treatment of the cardiomyopathy caused by transthyretin-mediated amyloidosis,” said Norman Stockbridge, MD, PhD, director of the Division of Cardiovascular and Renal Drugs in the FDA’s Center for Drug Evaluation and Research.
Find the full press release on the FDA website.