Acoramidis

BridgeBio’s Attruby, an oral drug for transthyretin amyloid cardiomyopathy (ATTR-CM), has been approved by the FDA, priced at $18,759.12 for a 28-day supply. It significantly improves survival and reduces heart disease-related hospitalizations but lacks a mortality benefit. BridgeBio partners with Bayer for European marketing and AstraZeneca’s Alexion for Japan. Analysts predict limited uptake due to Pfizer’s established Vyndaqel, but potential for $2.5 billion in global sales by 2035.

BridgeBio secures FDA approval for acoramidis (Attruby) for ATTR-CM, showing 42% reduction in mortality/cardiovascular events and 50% reduction in cumulative events at 30 months. The drug stabilizes transthyretin protein, reducing amyloid fibril build-up and disease progression.

The FDA approved Attruby, an oral treatment reducing heart-related deaths and hospital visits in adults with transthyretin amyloid cardiomyopathy (ATTR-CM). Attruby stabilizes weak TTR protein, slowing disease progression and improving heart health faster than standard treatments. A clinical trial showed Attruby reduced deaths and hospital visits by 42% and heart failure risk by 50%. Mild side effects were noted, but resolved easily. BridgeBio offers a patient support program for Attruby users.

Acoramidis (Attruby; BridgeBio) approved by FDA for transthyretin amyloid cardiomyopathy (ATTR-CM), based on ATTRibute-CM trial results. BridgeBio committed to providing the drug free for life to trial participants, while the drug's $244,000/year price draws scrutiny. Acoramidis mimics a natural TTR gene mutation, targeting ATTR-CM's root cause, and BridgeBio plans to seek approval in Europe, Japan, and Brazil. Additionally, gene-editing therapy nexiguran ziclumeran (nex-z; Intellia Therapeutics) shows promise in early trials for ATTR-CM.

The FDA approved acoramidis (Attruby) for ATTR-CM, reducing cardiovascular death and hospitalization. It's the first near-complete TTR stabilizer, showing a 42% reduction in mortality and 50% in hospitalization events.

Bridgebio Pharma's Attruby (acoramidis) gains FDA approval for ATTR-CM, challenging Pfizer's Vyndamax. Attruby, a next-gen oral TTR stabilizer, showed significant reduction in death and cardiovascular-related hospitalizations in a phase III study.

Acoramidis received FDA approval for treating transthyretin amyloid cardiomyopathy (ATTR-CM), based on significant results from the ATTRibute-CM study. The drug aims to reduce cardiovascular death and hospitalizations, showing a win ratio of 1.8 over placebo. Acoramidis stabilizes TTR proteins, improving outcomes and offering a new treatment option for ATTR-CM patients.

BridgeBio Pharma's acoramidis (Attruby) wins FDA approval for treating ATTR cardiomyopathy, competing with Pfizer's tafamidis. Attruby, a near-complete TTR stabilizer, aims to reduce cardiovascular death and hospitalization. Despite initial trial setbacks, 30-month data supported approval, positioning Attruby as the first oral stabilizer with near-complete stabilization claims. BridgeBio estimates a $15-20 billion market, dominated by Pfizer, with Alnylam and AstraZeneca also entering the space. Attruby's pricing is competitive but above cost-effectiveness benchmarks, with ongoing European review and a Bayer licensing deal.

FDA approves BridgeBio’s Attruby (acoramidis) for ATTR-CM, the first treatment to near-completely stabilize Transthyretin (TTR). Attruby demonstrated rapid benefits in Phase III studies, reducing mortality and hospitalizations, and improving quality of life. The approval is based on the ATTRibute-CM study, with a European Medicines Agency decision expected in 2025.

Acoramidis (Attruby) received FDA approval for treating wild-type or variant transthyretin amyloidosis cardiomyopathy (ATTR-CM), reducing cardiovascular death and hospitalization. It offers near-complete TTR stabilization in an oral tablet, competing with Tafamidis. The approval was based on the ATTRibute-CM trial, showing favorable safety and efficacy profiles, though some endpoints lacked significant reduction. Acoramidis is priced at just under $19,000 for a 28-day supply and is also under review in Europe, Japan, and Brazil.