Akebia Therapeutics, a biopharmaceutical company with the purpose of bettering the lives of people impacted by kidney disease, announced the resubmission of its New Drug Application (NDA) to the FDA for vadadustat, Akebia's investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor, for the treatment of anemia due to chronic kidney disease (CKD) in adult patients on dialysis. Vadadustat is currently approved for use in 35 countries.
"We are pleased to have resubmitted the NDA for vadadustat following multiple discussions with the FDA and clear direction from the agency, a significant milestone that reflects our team's commitment to patients and conviction in the benefit we believe vadadustat can deliver to patients on dialysis," said John P. Butler, Chief Executive Officer of Akebia. "Our team assembled a comprehensive resubmission, which now includes post-marketing safety data from tens of thousands of patients in Japan where vadadustat is approved and has been in the market for more than three years. We look forward to working with the FDA during the review process and are eager to offer a new oral therapeutic to patients if approved."
Based on standard NDA resubmission review timelines, a letter from the FDA acknowledging that the resubmission is complete, classifying the resubmission, and setting the PDUFA date is expected in 30 days. Akebia expects the FDA to set a PDUFA date of six months from the date of submission.
Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special offers
from American Pharmaceutical Review – all delivered right to your inbox!
Sign up now!