The FDA has approved Attruby, a transthyretin stabilizer developed by BridgeBio Pharma for treating adults with transthyretin-mediated amyloid cardiomyopathy (ATTR-CM).
The therapy is designed to reduce cardiovascular death and hospitalizations related to the condition. The approval follows positive results from the phase 3 ATTRibute-CM study, which demonstrated significant reductions in mortality and hospitalizations compared to placebo.
The treatment is the first to achieve near-complete stabilization of transthyretin (TTR) and has been shown to preserve TTR’s native functions as a transport protein for thyroxine and vitamin A.
Over 30 months, the phase 3 study reported a 42% reduction in composite all-cause mortality and cardiovascular-related hospitalizations, and a 50% decrease in the cumulative frequency of cardiovascular hospitalizations. The therapy also improved quality of life and exercise capacity for patients.
BridgeBio Pharma has launched a patient support program, ForgingBridges, to help U.S. patients access the treatment. The program provides insurance assistance, financial aid, and support teams to guide patients.
The approval also triggers a $500 million milestone payment to BridgeBio under its royalty funding agreement. The company has submitted a marketing application to the European Medicines Agency, with a decision expected in 2025. BridgeBio has granted Bayer exclusive rights to commercialize the treatment in Europe.
