Otsuka's tolvaptan gets Priority Review

Otsuka Pharmaceutical Co. Ltd. (Tokyo, Japan) said FDA accepted and granted Priority Review to an NDA for tolvaptan to treat autosomal dominant polycystic kidney disease. The PDUFA date is Sept. 1. Last year, Otsuka reported that tolvaptan met the primary endpoint of slowing the annual rate of increase in total kidney volume vs. placebo in the Phase III TEMPO 3:4 trial in the indication (see BioCentury Extra, Nov. 5, 2012). ...