VOICE trial interim analysis shows Vafseo superior to ESA on composite endpoint; trial stopped

Akebia Therapeutics, Inc.

Win odds 1.16 (95% CI 1.06-1.28, p=0.0016) for all-cause mortality/hospitalization composite.
Hospitalizations per patient-year: 1.11 (Vafseo) vs 1.23 (ESA); incidence rate ratio 0.90 (p<0.05).
Mortality rates similar: 8.77% vs 8.78% per 100 patient-years; rate ratio 1.00 (CI 0.718-1.391).
Trial stopped on recommendation of Independent Data Monitoring Committee and Trial Steering Committee.
Results replicate safety findings from INNO2VATE phase 3 program; data to be submitted for scientific meeting.

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