Samsca filed with EMA for Polycystic Kidney Disease-Otsuka

The European Medicines Agency has accepted the submission of a marketing authorisation application for Samsca (tolvaptan), from Otsuka, for the treatment of autosomal dominant Polycystic Kidney Disease (ADPKD). Phase III clinical trial results that form the basis of the regulatory filing were published in the New England Journal of Medicine.

The data showed that over a 3-year period, the increase in total kidney volume in the tolvaptan group was 2.8% per year versus 5.5% per year in the placebo group. The composite end point favored tolvaptan over placebo (44 vs. 50 events per 100 follow-up-years), with lower rates of worsening kidney function (2 vs. 5 events per 100 person-years of follow-up) and kidney pain (5 vs. 7 events per 100 person-years of follow-up).