BridgeBio’s BEYONTTRA Wins ANVISA Approval in Brazil for ATTR-CM After Phase 3 ATTRibute-CM Success
Written By: Farha Farheen, PharmD
Reviewed By: Pharmacally Editorial Team
BridgeBio Pharma announced that the Brazilian Health Regulatory Agency (ANVISA) has granted marketing authorization for BEYONTTRA (acoramidis) for the treatment of adults with wild-type or variant transthyretin amyloidosis with cardiomyopathy (ATTR-CM), a progressive and potentially life-threatening disease caused by misfolded transthyretin proteins accumulating in the heart.
Acoramidis is an orally administered selective transthyretin (TTR) stabilizer designed to achieve near-complete (≥90%) TTR stabilization. According to the company, it is the first and only approved ATTR-CM treatment in the United States, European Union, United Kingdom, Switzerland, Japan, and Brazil with labeling specifying near-complete (≥90%) TTR stabilization.
The approval in Brazil was supported by results from the pivotal Phase 3 ATTRibute-CM trial (NCT03860935), which evaluated the efficacy and safety of acoramidis in 632 patients with symptomatic ATTR-CM associated with either wild-type or variant TTR. Participants were randomized in a 2:1 ratio to receive acoramidis or placebo for 30 months.
The study met its primary clinical endpoints at Month 30 by significantly reducing cardiovascular-related hospitalizations, improving survival, and preserving functional capacity and quality of life. Additional findings showed numerically fewer cumulative cardiovascular events as early as Month 1 in patients receiving acoramidis compared with placebo. The therapy also demonstrated a 42% reduction in the composite of all-cause mortality and recurrent cardiovascular hospitalizations through Month 30, along with a 50% reduction in the cumulative frequency of cardiovascular hospitalizations through Month 30 versus placebo.
Fábio Fernandes, Director at the Heart Institute of the Clinical Hospital of the University of São Paulo Medical School and an investigator in the ATTRibute-CM study, said the results represent an important advancement for patients with ATTR-CM, particularly in Brazil where delayed diagnosis and limited treatment options remain significant challenges. He noted that acoramidis demonstrated meaningful reductions in cardiovascular hospitalizations while helping preserve survival, functional capacity, and patient quality of life.
Jonathan Fox, Chief Medical Officer of BridgeBio Cardiorenal, stated that the ANVISA approval expands access to a new treatment option for patients living with ATTR-CM in Brazil and reflects the company’s ongoing effort to broaden global availability of the therapy.
Acoramidis was previously approved in the United States as Attruby in November 2024. Additional approvals followed in the European Union in February 2025, Japan in March 2025, and the United Kingdom in April 2025. The therapy remains under regulatory review in other global markets.
BridgeBio plans to commercialize BEYONTTRA in Brazil through a partnership with Biopas, a subsidiary of Swixx BioPharma. Commercial launch activities are expected to begin during the second half of 2026.
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About the Writer
Farha Farheen, PharmD, is a pharmacy professional with a strong interest in pharmacovigilance and clinical research. She has completed her Doctor of Pharmacy (Pharm.D) along with her internship as a Clinical Pharmacist. She has hands-on experience in adverse drug reaction (ADR) reporting, safety data documentation, and pharmacovigilance workflows, and is proficient in using VigiFlow. She is also a patent holder for an antibacterial formulation enriched with bioactive substances, granted by the German Patent and Trademark Office.