Akebia Therapeutics Inc. (NASDAQ:AKBA) has announced its Q3 2020 results for the quarter ended September 30, 2020, and also offered a business update that includes confirmation of completion of its Pre-NDA Meeting With the FDA for vadadustat.
Vadadustat is the company’s experimental oral hypoxia-inducible factor prolyl hydroxylase inhibitor currently in development. The investigational drug is for treating anaemia in adult patients due to chronic kidney disease for both those on dialysis and those on dialysis.
Akebia completes pre-NDA meeting
John Butler, the CEO and President of Akebia, said that the company recently completed its Pre-NDA meeting with the US FDA. This is a huge milestone for the company in developing the vadadustat program, and Akebia is on track for NDA submission in early 2021. Butler said that the NDA’s main component is the encouraging data from the global Phase 3 INNO2VATE program for treating anaemia due to CKD in adult patients in dialysis. The data was recently shared at the ASN Kidney Week.
The data was consistent and clear, indicating that vadadustat attained primary and important secondary efficacy endpoints. It also achieved primary and secondary safety endpoints of the study for patients on dialysis. Butler said that based on the pre-NDA meeting, the company is confident that the results support possible vadadustat approval for treating anaemia in CKD adult patients on dialysis. Vadadustat can be a new oral standard of care treatment to address unmet needs in patients in dialysis, including prevalent and incident dialysis patients.
Vadadustat to create $2 billion markets in the US
Subject to approval, this will translate to a $2 billion market opportunity in the US. Through Otsuka’s partnership, Akebia is looking forward to delivering innovative therapies to CKD patients on dialysis globally. Recently Otsuka and Akebia launched a campaign called Balancing Anemia Due to CKD to create awareness of anaemia due to CKD among healthcare providers to improve management of the disease. In August, the company launched vadadustat in Japan in partnership with Mitsubishi Tanabe Pharma Corp.