Otsuka reports Phase III data for tolvaptan for kidney disease

Otsuka Pharmaceutical Co. Ltd. (Tokyo, Japan) said tolvaptan met the primary endpoint of slowing the annual rate of increase in total kidney volume vs. placebo over three years in the Phase III TEMPO 3:4 trial to treat autosomal dominant polycystic kidney disease (ADPKD) (2.8% vs. 5.5%, p<0.001). Tolvaptan also met the secondary endpoint of reducing a composite of events of ADPKD progression vs. placebo (44 vs. 50 events per 100 person-years of follow-up years, p=0.01). The double-blind, international study enrolled 1,445 patients. Data were published in the New England Journal of Medicine and presented at the American Society of Nephrology meeting in San Diego. ...