The U.S. Food and Drug Administration (FDA) has approved acoramidis as a treatment to help reduce cardiovascular death and cardiovascular-related hospitalization in patients with transthyretin amyloid cardiomyopathy (ATTR-CM).

The approval of the near-complete TTR stabilizer comes following positive results from the ATTRibute-CM Phase 3 study, where acoramidis was compared with placebo in patients with symptomatic ATTR-CM. The trial’s primary endpoint – a four-component composite endpoint of all-cause mortality, cardiovascular-related hospitalization, NT-proBNP and 6-minute walk distance – was met successfully with a win ratio of 1.8 (p<0.0001).

“Encouraging data suggests [Attruby™ (acoramidis)] reduces all-cause mortality and cardiovascular hospitalization as early as three months after initiation of therapy,” said Martha Grogan, MD, FACC, in a BridgeBio press release. “With continued advances in therapy, this previously fatal disease is becoming a manageable chronic cardiovascular condition.”

Clinical Topics: Heart Failure and Cardiomyopathies

Keywords: ACC Advocacy, United States Food and Drug Administration, Cardiomyopathies