PFE Pfizer announces tafamidis receives breakthrough therapy designation from FDA
Pfizer announced that tafamidis received breakthrough therapy designation from the FDA for the treatment of patients with transthyretin cardiomyopathy, a rare, fatal, and underdiagnosed condition associated with progressive heart failure.This decision is supported by topline results from the tafamidis Phase 3 Transthyretin Cardiomyopathy, or ATTR-ACT, study, in which tafamidis demonstrated a statistically significant reduction in the combination of all-cause mortality and frequency of cardiovascular-related hospitalizations. 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
~~~~~~~~~~~~~~~~~~~~~~~~~~
Insider time imo