Pfizer Reports Positive Results From Phase 3 ATTR-ACT Study Of Tafamidis

(RTTNews) - Pfizer Inc. (PFE) said that the Tafamidis Phase 3 Transthyretin Cardiomyopathy (ATTR-ACT) study evaluating tafamidis for the treatment of transthyretin cardiomyopathy met its primary endpoint, demonstrating a statistically significant reduction in the combination of all-cause mortality and frequency of cardiovascular-related hospitalizations compared to placebo at 30 months.

The preliminary safety data showed that tafamidis was generally well tolerated in this population and no new safety signals were identified.

In 2011, tafamidis was granted orphan drug designation for transthyretin cardiomyopathy in both the EU and US.

In June 2017, the US Food and Drug Administration (FDA) granted Fast Track designation to tafamidis for transthyretin cardiomyopathy; additionally, in March 2018, the Ministry of Labor Health and Welfare in Japan granted SAKIGAKE designation to tafamidis for this indication.