AKBA - Akebia files marketing application for Vadadustat in anemia due to CKD

Akebia Therapeutics ([[AKBA]] +1.9%) announced that it submitted a New Drug Application (“NDA”) to the FDA seeking approval for Vadadustat for the treatment of anemia due to chronic kidney disease (“CKD”) in adults irrespective of their dialysis therapy.Within 60 days, the FDA will now determine if the NDA is complete and acceptable for review. The NDA submission did not have a priority review, the company said.Akebia and its partner Otsuka Pharmaceutical ([[OTSKF]] +3.0%) expect to submit a Marketing Authorization Application (“MAA”) for Vadadustat to the European Medicines Agency later this year.Last week, Akebia announced the Japanese approval for Riona to treat iron deficiency anemia in adults.

For further details see:

Akebia files marketing application for Vadadustat in anemia due to CKD