RegulatoryMay 6, 2026, 07:33 AM
BridgeBio's BEYONTTRA Approved in Brazil for ATTR-CM
AI Summary
BridgeBio Pharma announced that the Brazilian Health Regulatory Agency (ANVISA) has granted marketing authorization for acoramidis, branded as BEYONTTRA, for the treatment of wild-type or variant transthyretin amyloidosis with cardiomyopathy (ATTR-CM). This approval is based on positive Phase 3 ATTRibute-CM study results, showing significant reductions in cardiovascular events and improved survival. BEYONTTRA is now approved in Brazil, adding to its prior approvals in the U.S., EU, UK, Switzerland, and Japan, with commercialization in Brazil expected in the second half of 2026.
Key Highlights
- Brazilian ANVISA granted marketing authorization for BEYONTTRA (acoramidis) for ATTR-CM treatment.
- Phase 3 ATTRibute-CM study showed a 42% reduction in composite ACM and recurrent CVH events at Month 30.
- Study also demonstrated a 50% reduction in cumulative frequency of CVH events at Month 30.
- Acoramidis is now approved in 6 regions: U.S., EU, UK, Switzerland, Japan, and Brazil.
- Commercialization of BEYONTTRA in Brazil is expected to begin in the second half of 2026.
- Acoramidis is an orally administered near-complete (">=90%") transthyretin (TTR) stabilizer.