FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

FDA Clears New Heart Disease Treatments

May 13, 2019

The FDA has given the green light for two new treatments for heart disease caused by transthyretin mediated amyloidosis, a rare disease.

The agency granted approvals for Pfizer’s Vyndaqel (tafamidis meglumine) and Vyndamax (tafamidis) tablets for treating the disease, which involves the buildup of abnormal misfolded protein deposits. The condition was previously only treatable through symptom management and, in rare cases, heart or liver transplants.

The products reduce cardiovascular mortality and the frequency of cardiovascular-related hospital stays in patients with wild-type or hereditary forms of this rare disease, “giving them a chance for more time with their loved ones,” the company said.

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