Otsuka & Akebia Announce Submission Of New Drug Application To The FDA For Approval Of Akebia’s Vadadustat

Otsuka Pharmaceutical Co., Ltd. (Otsuka) announced that its collaborator Akebia Therapeutics, Inc. (Akebia) has submitted a New Drug Application (NDA) to the Food and Drug Administration in the U.S. (FDA) seeking approval for Akebia’s investigational drug vadadustat as an oral medication for the treatment of renal anemia due to chronic kidney disease (CKD) in adults who receive dialysis, and those who do not receive dialysis. Vadadustat recently completed its global Phase 3 development program for the treatment of anemia due to CKD. Vadadustat is not approved by the U.S. Food and Drug Administration or any regulatory authority . . .