Therapy Areas: Cardiovascular
Pfizer's phase three transthyretin cardiomyopathy drug study meets primary endpoint
3 April 2018 -

US-based Pfizer has met its primary endpoint in the Tafamidis phase three study intended for the treatment of transthyretin cardiomyopathy, it was reported on Monday.

The product demonstrated a statistically significant decrease in the combination of all-cause mortality and frequency of cardiovascular-related hospitalisations compared to placebo at 30 months. The preliminary safety data indicated that the product was generally well tolerated in this population and no new safety signals were identified.

Pfizer's ATTR-ACT study was designed to evaluate clinically meaningful results for the use of the product as a treatment for patients with transthyretin cardiomyopathy, a rare, fatal, and underdiagnosed condition associated with progressive heart failure. ATTR-ACT is a Phase three international, multicentre, double-blind, placebo-controlled, randomised, three-arm clinical study of 441 patients that investigated the efficacy, safety, and tolerability of an oral daily dose of 20 mg or 80 mg tafamidis meglumine capsules compared to placebo.

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