PALO ALTO, Calif. — May 6, 2026 — Leads & Copy —
BridgeBio Pharma, Inc. (Nasdaq: BBIO) announced that the Brazilian Health Regulatory Agency (ANVISA) has granted marketing authorization for acoramidis, under the brand name BEYONTTRA. This approval allows the drug to be used for treating wild-type or variant transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM).
Acoramidis, a selective small molecule, is administered orally and acts as a near-complete (≥90%) stabilizer of transthyretin (TTR).
Dr. Fábio Fernandes, Director at the Heart Institute of the Clinical Hospital of the University of São Paulo Medical School (HCFMUSP), highlighted the significance of the ATTRibute-CM results. He noted that the results represent a major advancement for patients with ATTR-CM, who often face an earlier and more aggressive disease progression. He emphasized the positive impact of acoramidis in reducing cardiovascular-related hospitalizations, improving survival rates, and preserving functional capacity and quality of life for patients in Brazil.
The approval in Brazil was based on the pivotal ATTRibute-CM Phase 3 study, which demonstrated clear benefits of acoramidis on cardiovascular outcomes. The study involved 632 participants with symptomatic ATTR-CM, who were administered acoramidis or a placebo over 30 months. The results showed a significant reduction in cardiovascular-related hospitalizations, improved survival, and preservation of functional capacity and quality of life.
Jonathan Fox, M.D., Chief Medical Officer of BridgeBio Cardiorenal, stated that the ANVISA approval of BEYONTTRA is an important step forward for Brazilian patients living with ATTR-CM. He noted that the approval brings new hope to communities where ATTR-CM is increasingly recognized, and reflects the company’s commitment to ensuring access to transformative care for patients worldwide.
Acoramidis has already been approved as Attruby® by the U.S. FDA in November 2024, and as BEYONTTRA by the European Commission in February 2025, the Japanese Ministry of Health, Labour, and Welfare (MHLW) Agency in March 2025, and the UK Medicines and Healthcare Products Regulatory Agency in April 2025. All of these approvals include labels specifying near-complete stabilization of TTR. The drug is also under review by other global regulatory agencies.
BridgeBio will partner with Biopas, a Swixx BioPharma company, to commercialize BEYONTTRA in Brazil. Commercialization efforts are expected to begin in the second half of 2026.
BEYONTTRA is indicated for the treatment of wild-type or variant transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM). Full prescribing information for Brazil will be available through ANVISA.
Attruby® (acoramidis) is a transthyretin stabilizer indicated for the treatment of the cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular death and cardiovascular-related hospitalization.
Adverse reactions reported in patients treated with Attruby included diarrhea (11.6% vs 7.6%) and upper abdominal pain (5.5% vs 1.4%) compared to placebo. Discontinuation rates due to adverse events were similar between patients treated with Attruby versus placebo (9.3% and 8.5%, respectively).
BridgeBio Pharma, Inc. (Nasdaq: BBIO) is focused on discovering, creating, testing, and delivering transformative medicines to treat patients suffering from genetic diseases.
Source: BridgeBio Pharma, Inc.
