regulatory
confidence high
sentiment positive
materiality 1.00
FDA approves BridgeBio's Attruby (acoramidis) for ATTR-CM to reduce CV death and hospitalization
BridgeBio Pharma, Inc.
- Attruby is first and only approved TTR stabilizer with label specifying near-complete stabilization (≥90%).
- Phase 3 ATTRibute-CM: 42% reduction in composite ACM and recurrent CVH at Month 30; 50% reduction in cumulative CVH events.
- BridgeBio to receive $500M payment under royalty funding agreement upon approval.
- List price: $18,759.12 for 28-day supply; free for life for U.S. trial participants.
- MAA submitted to EMA; decision expected in 2025; Bayer has exclusive EU commercialization rights.