Akebia Therapeutics Inc (NASDAQ:AKBA) filed an NDA (New Drug Application) for its Vadadustat with the US FDA to treat adult patients suffering from anemia inducted by chronic kidney disease (CKD). It can also be used to treat adults who are not on dialysis.
CEO of Akebia, John P. Butler, said the company achieved a significant in filing the NDA for its innovative drug formulation – vadadustat. It is vital for patients living with anemia caused by CKD and its partners as well.
Otsuka Pharmaceutical Co. Ltd (Otsuka), a collaborator of Akebia, and the team at Akebia played a significant role in submitting NDA. They have included data gathered from more than 8,000 patients, who took part in 36 clinical studies of vadadustat.
Akebia will work with FDA in the review of vadadustat. John said the company is excited to coordinate with its associates in advancing the development of vadadustat and benefit patients.
60 days to review NDA
As per the standard timelines of the US FDA, the regulator will review the NDA and determine its acceptance in 60 days.
Akebia will also work with Otsuka for MAA (Marketing Authorization Application) of vadadustat and submit to EMA (European Medicines Agency) in 2021.
Grants options to new employees
Under the NASDAQ LR (Listing Rule) 5635(c)(4), Akebia granted options to its 19 newly recruited employees. They can acquire an aggregate of 131,000 shares of the company on March 31, 2021. The exercise price of each share is $3.38.
John will participate in the 20th ANVHC (Annual Needham Virtual Healthcare Conference) on April 15, 2021.
Akebia will show the data from April 6 to 10, 2021, through a virtual conference at NKF SCM21 (National Kidney Foundation 2021 Spring Clinical Meetings). The poster under the title – Drug interaction trial of vadadustat together with Digoxin and cyclosporine presents the details of phase 1 clinical trial that evaluates cyclosporine’s effectiveness vadadustat exposure.
Akebia recently completed the phase 3 clinical trial of vadadustat to treat patients suffering from CKD-induced anemia.
Pharmaceuticals and Medical Devices Agency approved Japan Tobacco Inc, a collaboration partner of Akebia, to treat patients suffering from iron deficiency anemia using Riona Tablets 250mg in Japan.