BridgeBio Pharma Inc. (BBIO) has announced that the U.S. Food and Drug Administration has approved Attruby, also known as acoramidis, as a treatment for adults suffering from Transthyretin amyloid cardiomyopathy (ATTR-CM). This orally-administered drug acts as a nearly complete stabilizer of Transthyretin, aiming to decrease both cardiovascular-related mortality and hospitalizations.
The FDA's approval was informed by the successful outcomes of the ATTRibute-CM Phase 3 study, which demonstrated that Attruby not only significantly reduced deaths and cardiovascular-related hospitalizations but also enhanced patients' quality of life.
Upon receiving this approval, BridgeBio is positioned to secure a $500 million payment through its royalty funding agreement. Additionally, the company has filed a Marketing Authorization Application with the European Medicines Agency, with a verdict anticipated in 2025. For the European market, BridgeBio has accorded exclusive commercialization rights of acoramidis for ATTR-CM to Bayer.