VIDEO: New ATTR-CM drug linked to positive data as FDA approaches final decision

Transthyretin amyloid cardiomyopathy (ATTR-CM) patients treated with the amyloidosis drug acoramidis are associated with significantly lower mortality and hospitalization rates, according to new 42-month data from the ATTRibute-CM phase 3 trial. Acoramidis was just approved by the U.S. Food and Drug Administration (FDA), making it the second ATTR-CM treatment to gain approval after Pfizer’s tafamidis.

The data were presented as a late-breaking trial during the American Heart Association (AHA) 2024 Scientific Sessions conference in Chicago by Daniel Judge, MD. Judge is the director of the cardiovascular genetics program, the Edwin W. and Teresa H. Rogers Endowed Chair for Cardiovascular Research and a professor of medicine at the Medical University of South Carolina. He spoke about the findings in an interview with Cardiovascular Business.

"Previously, we had shown that all-cause mortality, cardiovascular hospitalization and six-minute walk test distance was better. We reached statistical significance from the prior work, but that wasn't enough for some of the people who were looking for a clear mortality benefit in a disease that causes so much death. And now as we extend the study, we do see a mortality benefit that's very clear," Judge explained.