Otsuka's tolvaptan meets in Phase III for ADKPD

Otsuka Pharmaceutical Co. Ltd. (Tokyo, Japan) reported data from the Phase III REPRISE trial in 1,370 patients with autosomal dominant polycystic kidney disease (ADPKD) showing that once-daily 45-120 mg oral tolvaptan met the primary endpoint of reducing the rate of kidney function decline as measured by estimated glomerular filtration rate (eGFR) from baseline to 12 months vs. placebo (decline of 2.34 mL/min/1.73 m² vs. a decline of 3.61 mL/min/1.73 m^{2, p<0.001}). Specifically, tolvaptan reduced the rate of decline by 35% compared to placebo. Tolvaptan led to elevated alanine aminotransferase (ALT) levels in 5.6% of patients vs. 1.2% of patients in the placebo arm.

Secondary endpoints in the double-blind, international trial include annualized slope of eGFR, pharmacokinetics, urine osmolality and specific gravity...