Attruby: A Game-Changer In ATTR-CM Treatment With Record-Breaking Sales And Clinical Success
FDA Approval Attruby Market Impact
Attruby™ (acoramidis), developed by BridgeBio Pharma, received FDA approval in November 2024 as the first near-complete (≥90%) transthyretin (TTR) stabilizer for transthyretin amyloid cardiomyopathy (ATTR-CM), a progressive and often fatal heart condition.
The drug’s launch has exceeded expectations, generating $36.7 million in Q1 2025 sales—far surpassing Wall Street’s projected $12 million.
By late April 2025, over 2,000 prescriptions had been written by 756 healthcare providers, signaling rapid adoption in a market long dominated by Pfizer’s Vyndaqel.
Mechanism Of Action: Superior TTR Stabilization
Attruby works by mimicking a natural “rescue mutation” (T119M) that stabilizes TTR proteins, preventing their misfolding and subsequent amyloid buildup in the heart.
Unlike Pfizer’s tafamidis, which offers partial stabilization, Attruby achieves ≥90% TTR stabilization, leading to faster and more durable clinical benefits. In the ATTRibute-CM Phase 3 trial, Attruby demonstrated:
- A 42% reduction in all-cause mortality and recurrent cardiovascular hospitalizations at 30 months.
- A 50% decrease in cardiovascular hospitalizations.
- Significant symptom improvement in as little as 3 months.
Clinical Efficacy: Rapid And Durable Benefits
The ATTRibute-CM study, involving 632 patients, showed that Attruby not only slowed disease progression but also improved functional capacity, as measured by the 6-minute walk test and Kansas City Cardiomyopathy Questionnaire.
Notably, a prespecified analysis revealed a 59% risk reduction in mortality and hospitalization for patients with variant ATTR-CM (ATTRv), a subgroup with historically poor outcomes.
These results position Attruby as a potential first-line therapy, particularly for high-risk patients.
Safety And Patient Access Programs
Attruby’s safety profile is favorable, with most adverse events being mild. BridgeBio has implemented ForgingBridges™, a patient support program offering financial assistance and insurance navigation to ensure broad access.
Additionally, the company provides lifetime free medication for U.S. clinical trial participants, underscoring its patient-centric approach.
Global Expansion And Future Prospects
Following U.S. approval, Attruby (marketed as Beyonttra™ outside the U.S.) gained approvals in the EU, Japan, and the UK in early 2025, with Bayer leading European commercialization.
Analysts now project 2025 sales could reach $200 million, up from prior estimates of $150 million. BridgeBio is also exploring combination therapies and advancing pipeline candidates for rare genetic diseases, including limb-girdle muscular dystrophy and hypochondroplasia.
Conclusion
Attruby’s success marks a turning point in ATTR-CM treatment, offering faster, more complete stabilization of TTR than existing therapies.
With strong clinical data, rapid market uptake, and global expansion, BridgeBio is poised to challenge Pfizer’s dominance while improving outcomes for patients worldwide.
As precision medicine evolves, Attruby exemplifies how targeted therapies can transform fatal diseases into manageable conditions.
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