Benzinga | Oct 29, 2021 08:18AM EDT

Akebia Announces Otsuka's Submission Of Initial Marketing Authorization Application To the European Medicines Agency For Vadadustat For Treatment Of Patients With Anemia Due To Chronic Kidney Disease

Akebia Therapeutics, Inc. (NASDAQ:AKBA), a biopharmaceutical company with the purpose of bettering the lives of people impacted by kidney disease, and its collaborator, Otsuka Pharmaceutical Co., Ltd. (Otsuka), today announced that Otsuka Pharmaceutical Netherlands B.V. has submitted an initial marketing authorization application (MAA) to the European Medicines Agency for vadadustat, an investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor, for the treatment of anemia associated with chronic kidney disease (CKD) in adults.

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"Otsuka's submission of the vadadustat MAA is an important step toward potentially bringing to market a new oral treatment option for patients living with anemia due to CKD. We are pleased to have collaborated on a comprehensive submission," said John P. Butler, Chief Executive Officer of Akebia. "We will continue to work closely with Otsuka through the review process, and to ensure we are well positioned to support a successful commercial launch of vadadustat in Europe, if approved."

"We are excited to reach this regulatory milestone in collaboration with Akebia, demonstrating our continued commitment to patients with chronic kidney disease," said Andy Hodge, CEO of Otsuka Pharmaceutical Europe Ltd. and Otsuka Pharmaceutical Development and Commercialisation Europe GmbH.

Akebia and Otsuka are collaborating on the development and commercialization of vadadustat in the U.S., Europe, China, Russia, Canada, Australia, the Middle East, and certain other territories.