BridgeBio gets Brazil approval for ATTR-CM heart drug acoramidis

BridgeBio Pharma Inc (NASDAQ: BBIO) announced that Brazil's health regulatory agency ANVISA approved acoramidis, marketed as BEYONTTRA, for treating transthyretin amyloidosis with cardiomyopathy in adult patients.

The approval covers treatment of both wild-type and variant forms of the heart condition. Acoramidis is an oral medication that stabilizes at least 90% of transthyretin protein, according to the company's statement.

The Brazilian authorization follows approvals in multiple markets. The U.S. Food and Drug Administration approved acoramidis as Attruby in November 2024, while European, Japanese, and UK regulators granted approval in early 2025.

ANVISA's decision was based on results from the Phase 3 ATTRibute-CM study involving 632 participants. The trial showed a 42% reduction in composite cardiovascular death and recurrent cardiovascular hospitalization events compared to placebo at 30 months. The study also demonstrated a 50% reduction in cumulative cardiovascular hospitalization events relative to placebo.

BridgeBio will partner with Biopas, a Swixx BioPharma company, to commercialize the drug in Brazil. The companies expect to begin sales in the second half of 2026.

The approval addresses treatment of ATTR-CM, a progressive disease where misfolded proteins accumulate in heart tissue. The condition can occur in patients with normal transthyretin genes or those carrying genetic variants.

Information for this report was based on a company press release statement.

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