Acoramidis

Attruby, a near-complete TTR stabilizer, is the first FDA-approved treatment for ATTR-CM, reducing cardiovascular death and hospitalizations. It demonstrated rapid benefits, with a 42% reduction in composite ACM and recurrent CVH events, and a 50% reduction in CVH events at Month 30. BridgeBio will provide Attruby free for life to U.S. clinical trial participants and offers extensive access programs. The company will receive a $500 million payment under its royalty funding agreement and plans global approvals, starting with Europe in 2025.

FDA approves BridgeBio Pharma's Attruby (acoramidis) for transthyretin amyloidosis cardiomyopathy, priced at $244,000 annually. The approval positions ATTR cardiomyopathy as a commercial battleground, with Pfizer's tafamidis and Alnylam's vutrisirian as competitors. BridgeBio aims for a 30% market share and plans a head-to-head trial against tafamidis.

BridgeBio and patient advocates celebrate FDA approval of acoramidis/Attruby for ATTR-CM, with plans for global expansion. The approval brings competition to the ATTR-CM market, with Pfizer's tafamidis facing new rivals like Alynlam's vutrisiran.

The FDA approved acoramidis (Attruby) for transthyretin amyloid cardiomyopathy (ATTR-CM), reducing cardiovascular death and hospitalization. Acoramidis, an orally-administered TTR stabilizer, showed a 42% reduction in mortality and recurrent hospitalization events at Month 30 in a phase 3 trial.

FDA approves BridgeBio's Attruby (acoramidis) for transthyretin amyloid cardiomyopathy (ATTR-CM), affecting over 400,000 globally, marking the first new treatment in five years.

FDA approves Attruby (acoramidis) to reduce cardiovascular death and hospitalization in patients with ATTR-CM, based on positive ATTRibute-CM Phase 3 study results.

ATTR-CM patients benefit more from acoramidis treatment the earlier it starts, with significant reductions in cardiac mortality and hospitalizations. Acoramidis stabilizes transthyretin protein effectively, offering a new treatment option for ATTR-CM, alongside tafamidis. Early diagnosis and biomarkers like NT-proBNP and prealbumin levels improve patient outcomes.

BridgeBio's acoramidis, a transthyretin stabilizer, may soon compete with Pfizer's tafamidis for treating transthyretin amyloid cardiomyopathy (ATTR-CM). Acoramidis, with an FDA action date of Nov. 29, could see approval, potentially challenging Pfizer's established position in the $5.2 billion ATTR-CM market. BridgeBio's Phase III trial showed acoramidis improved survival rates and reduced hospitalizations, though it faces challenges like twice-daily dosing and lack of mortality benefit data compared to tafamidis. Emerging RNA therapies, like Alnylam's Amvuttra and Intellia's nex-z, also show promise in treating ATTR-CM.