Pfizer Inc. announced today that the FDA granted Fast Track designation to tafamidis, the company’s investigational treatment for transthyretin cardiomyopathy (TTR-CM). This rare disease is associated with progressive heart failure. Currently in Phase 3 clinical development for TTR-CM, tafamidis is being evaluated for its potential to reduce mortality and cardiovascular-related hospitalizations.
The FDA’s Fast Track approach is a process designed to facilitate the development and expedite the review of new drugs and vaccines intended to offer real hope for treatment options for people living with rare diseases.
Pfizer’s ATTR-ACT: Transthyretin Amyloid Cardiomyopathy Tafamidis Study is the first Phase 3 clinical study initiated in TTR-CM and includes both patients with variant transthyretin familial amyloid cardiomyopathy (TTR-FAC), which is the hereditary form of the disease, and those with wild-type TTR-CM, which is not hereditary and may occur as people age. The ATTR-ACT study is fully enrolled and is anticipated to be completed in the first half of 2018.
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