Akebia Gets FDA Acceptance Of Resubmission To NDA Of Vadadustat For Treatment Of Anemia Due To CKD

(RTTNews) - The U.S. Food and Drug Administration has acknowledged that the resubmission to Akebia Therapeutics Inc.'s (AKBA) New Drug Application for vadadustat as a treatment for anemia due to chronic kidney disease or CKD in adult patients on dialysis, was complete, the company said in a statement on Wednesday.

The FDA has classified this as a class 2 response, which results in a six-month review period from the date of resubmission, and the FDA set a user fee goal date or "PDUFA" date of March 27, 2024.

"With this significant milestone, we expect to have vadadustat available shortly following an approval and are preparing for a commercial launch in the second half of 2024 as we are eager to offer an alternative oral medication to U.S. dialysis patients if approved," said John Butler, Chief Executive Officer of Akebia.

Akebia noted that its resubmission to its NDA addressed the issues raised in the complete response letter. The filing included post-marketing safety data from tens of thousands of patients in Japan where vadadustat is approved and has been on the market for more than three years. Vadadustat is currently approved for use in 35 countries.

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