FDA grants breakthrough therapy designation for tafamidis for the treatment of patients with transthyretin cardiomyopathy

Pfizer

23 May 2018 - Pfizer announced today that tafamidis received breakthrough therapy designation from the US FDA for the treatment of patients with transthyretin cardiomyopathy, a rare, fatal, and under-diagnosed condition associated with progressive heart failure.

This decision is supported by topline results from the tafamidis Phase 3 Transthyretin Cardiomyopathy (ATTR-ACT) study, in which tafamidis demonstrated a statistically significant reduction in the combination of all-cause mortality and frequency of cardiovascular-related hospitalisations

Currently, there are no approved pharmacological treatments specifically indicated for this disease, and the average life expectancy for people with transthyretin cardiomyopathy is 3 to 5 years from diagnosis.

Read Pfizer press release

Michael Wonder

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Michael Wonder