Press release
Alnylam Reports Positive Topline Results from HELIOS-B Phase 3 Study of Vutrisiran, Achieving Statistical Significance on Primary and All Secondary Endpoints in Both Overall and Monotherapy Populations
− Achieved 28% and 33% Reduction in Composite of All-Cause Mortality and Recurrent Cardiovascular Events in the Overall and Monotherapy Populations,
About this update from Alnylam Pharmaceuticals, Inc.
[{"type":"text","content":"\n− Achieved 28% and 33% Reduction in Composite of All-Cause Mortality and Recurrent Cardiovascular Events in the Overall and Monotherapy Populations, Respectively –\n\n\n− Reduced All-Cause Mortality by 36% and 35% in the Overall and Monotherapy Populations, Respectively, in a Pre-Specified Secondary Endpoint –\n\n\n− Demonstrated Clinically Significant Benefits on 6-Minute Walk Test, Kansas City Cardiomyopathy Questionnaire and NYHA Class – Key Measures of Disease Progression –\n\n\n− Observed Consistent Effects in All Key Subgroups, Including Baseline Tafamidis –\n\n\n− Demonstrated Encouraging Safety, Consistent with Established Profile –\n\n\n− Alnylam to File a U.S. Supplemental New Drug Application Using a Priority Review Voucher –\n\n\n− Alnylam to Host Conference Call Today at 8:00 am ET –\n\n\n CAMBRIDGE, Mass.--(BUSINESS WIRE)--\nAlnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced positive topline results from its HELIOS-B Phase 3 study of vutrisiran, an investigational RNAi therapeutic in development for the treatment of ATTR amyloidosis with cardiomyopathy (ATTR-CM).\n\n\nThe study met the primary endpoint, demonstrating a statistically significant reduction in the composite of all-cause mortality and recurrent cardiovascular (CV) events during the double-blind period in both the overall population (HR 0.718, p-value 0.0118; n=654) and in the monotherapy population (patients not receiving tafamidis at baseline; HR 0.672, p-value 0.0162; n=395).\n\n\nThe study also demonstrated statistically significant improvements across all secondary endpoints in both the overall and monotherapy populations. This includes key measures of disease progression: 6-minute walk test (6-MWT), Kansas City Cardiomyopathy Questionnaire (KCCQ) and New York Heart Association (NYHA) Class at Month 30 (p","length":2970,"tagName":"div"}]