Pfizer New Phase 3 Cardiomyopathy Study Presented at Meeting

Pfizer Inc. (NYSE:PFE) announced today that additional sensitivity and post-hoc analyses from the Tafamidis Phase 3 Transthyretin Amyloid Cardiomyopathy (ATTR-ACT) study provide further detail on the effect of tafamidis across wild-type, hereditary, and New York Heart Association (NYHA) class sub-groups of patients with transthyretin amyloid cardiomyopathy (ATTR-CM).1 Tafamidis is the only investigational treatment that has completed a Phase 3 trial evaluating its safety and efficacy for the treatment of ATTR-CM.1 ATTR-CM is a rare, fatal, and underdiagnosed condition associated with progressive heart failure for which there are currently no approved pharmacologic treatments.2

The findings were presented today during the Late Breaking Clinical Trials session at the Heart Failure Society of America 22nd Annual Scientific Meeting in Nashville, TN.The primary results were presented at the ESC Congress 2018 in Munich, Germany on August 27, 2018 and simultaneously published online in the New England Journal of Medicine (NEJM).

The broader primary results showed tafamidis significantly reduced the hierarchical combination of both all-cause mortality and frequency of cardiovascular-related hospitalizations compared to placebo over a 30-month period (P=0.0006) in patients with wild-type and hereditary ATTR-CM.1 A new sensitivity analysis presented today also demonstrated a significant reduction in the combination of all-cause mortality and frequency of all-cause hospitalization compared to placebo over a 30-month period (P=0.0088).1

In addition, tafamidis reduced the risk of all-cause mortality across all sub-groups (wild-type, hereditary and NYHA I, II and III functional class) versus placebo. This included a 29% and 31% reduction in the risk of death observed in wild-type (HR 0.71; 95% CI [0.474, 1.052]) and hereditary (HR 0.69; 95% CI [0.408,1.167]) sub-groups, respectively.1 Across wild-type and hereditary sub-groups, tafamidis consistently reduced the decline in the six minute walk test distance, a measure of functional capacity, and aspects of quality of life measured by the Kansas City Cardiomyopathy Questionnaire – Overall Score, compared with placebo at Month 30. Tafamidis was also well tolerated, with an observed safety profile comparable to placebo.1

“These additional insights further support tafamidis as a potential treatment option for people with wild-type or hereditary ATTR-CM,” said Brenda Cooperstone MD, Senior Vice President and Chief Development Officer, Rare Disease, Pfizer Global Product Development. “We look forward to learning more through further analyses of this study and continue to work with global regulatory authorities to bring this medicine to patients.”

https://www.marketscreener.com/PFIZER-23365019/news/Pfizer-New-Sub-group-Analyses-From-the-Tafamidis-Phase-3-Transthyretin-Amyloid-Cardiomyopathy-Stud-27283052/