University of the Pacific

FDA Approves Attruby (Acoramidis) for Transthyretin Amyloid Cardiomyopathy (ATTR-CM)

6 months ago

• The FDA has approved Attruby (acoramidis) for treating transthyretin amyloid cardiomyopathy (ATTR-CM), offering a new hope for patients with this rare heart condition. • Attruby, a TTR stabilizer, demonstrated significant reduction in cardiovascular death and hospitalization in the ATTRibute-CM Phase 3 trial. • The approval provides an additional treatment option alongside existing therapies, potentially improving heart health and quality of life for ATTR-CM patients. • BridgeBio offers patient support programs like ForgingBridges™ to assist with access, insurance, and financial aid for Attruby treatment.

Acoramidis Gains Global Momentum: FDA Approval, EU Recommendation, and Promising Clinical Data

6 months ago

• Acoramidis (Attruby), developed by Stanford Medicine and BridgeBio, receives FDA approval for transthyretin amyloid cardiomyopathy (ATTR-CM) treatment, marking a significant milestone. • The European Medicines Agency's CHMP recommends acoramidis for EU marketing authorization based on positive Phase 3 ATTRibute-CM trial results. • Clinical trials demonstrate acoramidis' efficacy in reducing cardiovascular-related hospitalizations and improving survival rates for ATTR-CM patients. • Bayer and BridgeBio collaborate to commercialize acoramidis, with Bayer holding EU rights and plans for a launch in Europe in early 2025.