FDA Approves Attruby to Reduce Cardiovascular Death and Cardiovascular-Related Hospitalization in Patients with ATTR-CM
BridgeBio Pharma, Inc. has announced that the U.S. Food and Drug Administration (FDA) approved Attruby™ (acoramidis), for the treatment of adults with cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis (ATTR-CM) to reduce cardiovascular death and cardiovascular-related hospitalization.
The FDA approval is based on positive results seen in the ATTRibute-CM Phase 3 study, where Attruby significantly reduced death and cardiovascular-related hospitalization, and improved quality of life.
- Attruby is the first and only approved product with a label specifying near-complete stabilization of TTR. It mimics a naturally occurring “rescue mutation” of the TTR gene that targets the root cause of ATTR-CM.
- Attruby has been shown to preserve the native function of TTR as a transport protein of thyroxine and vitamin A and to demonstrate benefit on cardiovascular outcomes.
Source: BridgeBio Pharma, Inc.