Akebia Therapeutics Inc (NASDAQ:AKBA) has put in a lot of tenacity and innovation in developing novel therapeutics for people living with kidney disease. Over the years, it has impacted the renal community and continues to lay new care standards with advanced treatments. Today the company has announced the accomplishment of primary and key secondary efficacy endpoint from a PRO2TECT global phase 3 program of Vadadustat.
In each of the two PRO2TECT studies, Vadadustat demonstrated non-inferiority (NI) to darbepoetin alfa. However, it failed to meet the primary safety endpoint of the PRO2TECT program.
Presentation of Full Dataset from Global Phase 3 Program (INNO2VATE and PRO2TECT)
INNO2VATE is the first of Akebia’s two global Phase 3 programs. According to the company’s CEO, John P. Butler, if approved, it would be very rewarding to have vadadustat as a treatment for anemia occasioned by chronic kidney disease (CKD) in adult patients on dialysis.
Both INNO2VATE and PRO2TECT are multicenter, open-label, and active-controlled studies. The global INNO2VATE program enrolled 3,923 adult patients on dialysis. A starting oral dose of 300 mg of Vadadustat was administered once daily before being adjusted in 150 mg increments.
Plans are now underway by Akebia for the presentation of the full dataset from the two programs in an upcoming medical conference. The data will also be published in peer-reviewed journals before the company can submit to the FDA a New Drug Application (NDA) for vadadustat.
A Hopeful Path of Approval for Vadadustat in Non-dialysis
‘’…It is extremely rewarding to see this program yield clear, consistent, straightforward results. We believe our data uniquely positions vadadustat as a potential new oral standard of care for treating all populations of dialysis patients…’’ Butler explained.
Having delivered positive top-line efficacy results and safety from INNO2VATE, the company feels this is a significant accomplishment. However, given that there were no major adverse cardiovascular events (MACE) from Vadadustat in dialysis patients, Butler says, they will try to bring it on to the non-dialysis market.
Meanwhile, together with its collaborator Otsuka Pharmaceutical Co. Ltd, Akebia is preparing a Marketing Authorization Application (MAA) to be submitted to the European Medicines Agency (EMA).