FDA official announcements and press releases

Alnylam's Vutrisiran Shows Promise in HELIOS-B Phase 3 Study at European Society of Cardiology

Aug 30, 2024, 11:17 AM

Alnylam Pharmaceuticals presented detailed results from its HELIOS-B Phase 3 study of the drug Vutrisiran, also known as Amvuttra, at the European Society of Cardiology Congress. The study focused on patients with transthyretin amyloidosis with cardiomyopathy (ATTR-CM). Vutrisiran showed a substantial reduction in the risk of death and serious cardiovascular events. Specifically, the drug achieved a 28% reduction in the primary composite of all-cause mortality and recurrent cardiovascular events, and a 31% and 36% reduction in all-cause mortality during the 33-36-month double-blind period and up to month 42, respectively. Despite these positive results, Alnylam's shares fell nearly 11% as the data did not meet heightened investor expectations. The company's heart drug faces competition from BridgeBio's Acoramidis, which showed promising results in its ATTRibute-CM study. Analysts suggest that Vutrisiran may not be superior to Acoramidis, with comparative data indicating a higher relative risk reduction for Acoramidis.