Pfizer Inc. said the U.S. Food and Drug Administration accepted the applications for two different types of its rare heart condition drug tafamidis, granting one of them an expedited review.
Tafamidis is meant to treat transthyretin amyloid, or ATTR, cardiomyopathy, and the meglumine type of the drug has been granted priority review with a decision expected in July.
The free acid form of tafamidis will have a standard review with a decision expected in November.
ATTR cardiomyopathy, a hard-to-diagnose disease, occurs due to the collection and deposition of the transthyretin protein in the heart, which can result in the organ's failure.
The New York-based pharmaceutical company's application is supported by results from a phase 3 study in which tafamidis reduced premature deaths and frequency of heart-related hospitalizations.
The FDA granted the fast-track and breakthrough therapy designation to tafamidis for ATTR cardiomyopathy in 2017 and 2018, respectively. Tafamidis received the orphan drug designation for the disease in both the EU and the U.S. in 2012.
Meanwhile, Japan's Ministry of Health, Labour and Welfare granted tafamidis a Sakigake designation — similar to the FDA's breakthrough therapy designation — in 2018.