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Efficacy and Safety Profile

VyndaqelTM significantly reduced the combination of all-cause mortality and CV-related hospitalizations vs. placebo over 30 monthsp=0.00065



VyndamaxTM significantly reduced the risk of all-cause mortality and frequency of CV-related hospitalizations vs. placebo5

VyndamaxTM reduced the time to first cardiovascular-related hospitalization at approx. 9 months after first dose vs. placebo5

>>Statistical analysis of individual components of the primary analysis overview:5

The components of the primary analysis, all-cause mortality and CV-related hospitalizations, were evaluated individually. All-cause mortality was analyzed with the use of a Cox proportional-hazards model, with treatment and the stratification factors treated as covariates. The CV-related hospitalization analysis was based on a Poisson regression model with treatment, TTR status (hereditary and wild-type), NYHA baseline class (NYHA Classes I and II combined versus NYHA Class III), treatment-by-TTR genotype interaction, and treatment-by-NYHA baseline classification interaction terms as factors.

>>Patient-years of treatment needed: 46

4 patient-years of treatment needed to prevent 1 CV-related hospitalization.

Heart transplantation, combined heart and liver transplantation, and cardiac mechanical assist device implantation are treated as equivalent to death in this analysis.