Akebia Resubmits FDA Application for Vadadustat in Dialysis-Dependent CKD Anemia

Key Insights

• Akebia Therapeutics has resubmitted its New Drug Application (NDA) to the FDA for vadadustat for anemia due to chronic kidney disease in adults on dialysis.
• The resubmission includes post-marketing safety data from tens of thousands of patients in Japan, where vadadustat is already approved.
• The FDA is expected to acknowledge the resubmission within 30 days and set a PDUFA date approximately six months from the submission date.

Akebia Therapeutics has announced the resubmission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for vadadustat, an investigational oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor. The application seeks approval for the treatment of anemia due to chronic kidney disease (CKD) in adult patients on dialysis. This follows discussions with the FDA and incorporates additional data to address previous concerns.

Comprehensive Resubmission

The resubmitted NDA includes post-marketing safety data from a large cohort of patients in Japan, where vadadustat has been available for over three years. This data encompasses tens of thousands of patients and aims to provide a more comprehensive safety profile for the drug. John P. Butler, Chief Executive Officer of Akebia, stated, "Our team assembled a comprehensive resubmission, which now includes post-marketing safety data... 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."

Regulatory Timeline

Akebia anticipates receiving an acknowledgment letter from the FDA within 30 days, which will classify the resubmission and set a Prescription Drug User Fee Act (PDUFA) date. The company expects the FDA to set a PDUFA date six months from the date of submission.

Vadadustat Mechanism of Action

Vadadustat is designed to mimic the physiological effects of altitude on oxygen availability. By inhibiting HIF-PH, vadadustat stabilizes hypoxia-inducible factor (HIF), which can lead to increased red blood cell production and improved oxygen delivery to tissues. It is already approved in 35 countries for treating symptomatic anemia due to CKD in adult patients on chronic maintenance dialysis and in Japan for both dialysis-dependent and non-dialysis dependent adult patients.

Anemia in Chronic Kidney Disease

Anemia is a common and significant complication of CKD, often leading to fatigue, cardiovascular problems, and reduced quality of life. Current treatments include erythropoiesis-stimulating agents (ESAs) and iron supplementation. Vadadustat, if approved, would offer an additional oral therapeutic option for managing anemia in this patient population.