Mitsubishi Tanabe planning Japanese submission for vadadustat

Akebia said partner Mitsubishi Tanabe plans to submit a regulatory application in Japan this year for vadadustat to treat anemia due to chronic kidney disease (CKD) after reporting that the product met the primary endpoints in two Japanese Phase III trials in the indication.

The open-label Phase III J01 trial enrolled 304 non-dialysis-dependent patients, and the double-blind Phase III J03 trial enrolled 323 dialysis-dependent patients...