BridgeBio's Beyonttra Gains Brazilian Approval for ATTR-CM Treatment

Event summary

  • ANVISA approved BridgeBio's Beyonttra (acoramidis) for ATTR-CM in Brazil, based on Phase 3 ATTRibute-CM study results.
  • Study showed 42% reduction in composite ACM and recurrent CVH events and 50% reduction in CVH events at Month 30.
  • BridgeBio partners with Biopas for commercialization in Brazil, expected to begin in H2 2026.
  • Acoramidis is the first near-complete (≥90%) TTR stabilizer approved in the U.S., EU, UK, Switzerland, Japan, and Brazil.

The big picture

BridgeBio's approval in Brazil expands the global reach of Beyonttra, a near-complete TTR stabilizer, addressing a critical unmet need in ATTR-CM treatment. This approval follows a series of regulatory wins in major markets, positioning BridgeBio as a key player in genetic disease therapeutics. The partnership with Biopas underscores the strategic importance of local commercialization expertise in emerging markets.

What we're watching

Commercialization Pace
The pace at which BridgeBio and Biopas can initiate commercialization efforts in Brazil and expand access to Beyonttra.
Regulatory Momentum
Whether BridgeBio can secure additional global regulatory approvals for acoramidis in other markets under review.
Market Penetration
How BridgeBio will position Beyonttra against existing treatments in Brazil and other approved markets.