FDA Approves BridgeBio’s Attruby for ATTR-CM Treatment

Details

announced the FDA approval of Attruby (acoramidis), an orally-administered near-complete (≥90%) stabilizer of Transthyretin (TTR) for treating adults with Transthyretin Cardiac Amyloidosis (ATTR-CM) to reduce cardiovascular death and hospitalization. Attruby demonstrated significant benefits in a Phase 3 study, including a 42% reduction in combined all-cause mortality and cardiovascular-related hospitalizations at 30 months, and a 50% reduction in the cumulative frequency of cardiovascular-related hospitalizations. The approval is based on positive results from the ATTRibute-CM Phase 3 study published in The New England Journal of Medicine. BridgeBio will offer Attruby free of charge to U.S. clinical trial participants for life. The list price for Attruby is $18,759.12 for a 28-day supply.

Items reported

Exhibits (1)

About BridgeBio Pharma Inc.

BridgeBio Pharma Inc. is a cutting-edge biotechnology company focused on discovering, developing, and delivering transformative medicines for patients with genetic diseases. The company's primary purpose is to bridge the gap in medical research and bring breakthrough therapies to those with rare and often overlooked genetic disorders. By utilizing a targeted approach, BridgeBio Pharma Inc. works across multiple sectors including dermatology, oncology, cardiology, neurology, and endocrinology. The company partners with academic institutions, research organizations, and industry leaders to harness the latest scientific advancements in genomics and biotechnology. Established with a mission to translate genetic research into real-world medical solutions, BridgeBio Pharma Inc. plays a significant role in the biopharmaceutical market. It is heavily involved in the early and late stages of drug development, positioning itself as a key player in the quest to address unmet medical needs. This focus on genetic-centric therapies underlines its importance in the rapidly evolving landscape of biotechnology and personalized medicine.