FDA Approves BridgeBio’s Attruby for ATTR-CM, Offering New Hope for Patients
FDA Approval:
The FDA has approved BridgeBio's Attruby (acoramidis) for the treatment of adults with transthyretin amyloid cardiomyopathy (ATTR-CM) to reduce cardiovascular death and cardiovascular-related hospitalization12.
Clinical Trial Results:
The approval is based on the ATTRibute-CM Phase III study, which showed that Attruby significantly reduced death, cardiovascular-related hospitalization, and improved quality of life in patients with ATTR-CM12.
TTR Stabilization:
Attruby is a near-complete (≥90%) stabilizer of Transthyretin (TTR), designed to mimic a naturally occurring “rescue mutation” of the TTR gene (T119M) that targets the root cause of ATTR-CM12.
Market Impact:
The approval sets up a potential three-way race in the ATTR-CM market between BridgeBio’s Attruby, Pfizer’s tafamidis (Vyndaqel and Vyndamax), and Alnylam’s Amvuttra4.
Pricing:
Attruby will be priced at $18,759.12 for a 28-day supply, equating to approximately $244,500 per year4.
Patient Support:
BridgeBio will provide Attruby free for life to U.S. clinical trial participants and offers a patient support services program, ForgingBridges, to help patients access the new therapy23.
Global Expansion:
BridgeBio has submitted a Marketing Authorization Application to the European Medicines Agency, with a decision expected in 2025, and has granted exclusive rights to Bayer to commercialize acoramidis for ATTR-CM in Europe23.
Sources:
1. https://www.genengnews.com/topics/drug-discovery/bridgebios-attruby-to-treat-heart-condition-attr-cm-receives-fda-approval/
2. https://bridgebio.com/news/attruby-acoramidis-a-near-complete-ttr-stabilizer-%E2%89%A590-approved-by-fda-to-reduce-cardiovascular-death-and-cardiovascular-related-hospitalization-in-attr-cm-patients/
3. https://www.globenewswire.com/news-release/2024/11/23/2986250/0/en/Attruby-acoramidis-a-Near-Complete-TTR-Stabilizer-90-approved-by-FDA-to-Reduce-Cardiovascular-Death-and-Cardiovascular-related-Hospitalization-in-ATTR-CM-Patients.html
4. https://www.biospace.com/drug-development/attr-cm-approval-for-bridgebio-could-trigger-tight-race-with-pfizer