Congratulations to the BridgeBio team Neil Kumar🎉! FDA has announced the approval of Attruby™ (acoramidis), a near complete TTR stabilizer (≥90%) for the treatment of adults with transthyretin amyloid cardiomyopathy (ATTR-CM) to reduce cardiovascular death and cardiovascular-related hospitalization. ATTR-CM is a rare and progressive disease where a protein called transthyretin (TTR) misfolds and forms harmful amyloid deposits in the heart. Over time, these deposits can lead to heart failure, making it difficult for the heart to pump blood properly. Although treatments for ATTR-CM have been limited, the approval of Attruby offers new hope for patients affected by this debilitating disease. The approval of acoramidis comes less than 10 months after BridgeBio Pharma announced the FDA’s acceptance of their New Drug Application (NDA) in February 2024. Attruby is the first and only approved product with a label specifying near-complete stabilization of TTR. Attruby has been shown to preserve the native function of TTR as a transport protein of thyroxine and vitamin A and to demonstrate benefits on cardiovascular outcomes, offering a new treatment option for those affected by this serious disease. #geneticdiseases #cardiomyopathy #rarediseases #clinicaltrial #amyloidosis #biomarker
We are excited to announce that the U.S. FDA approved our orally-administered near-complete (≥90%) stabilizer of TTR for the treatment of adult patients with transthyretin cardiac amyloidosis (ATTR-CM). Next, we're looking to pursue approvals globally in Europe, Japan, and Brazil, and will continue exploring the full potential of this treatment. We are proud of the opportunity to serve patients within this community. Learn more: https://bit.ly/3V5wVp4