The approval of vadadustat (Vafseo) from Akebia Therapeutics was based on data from the phase 3 INNO2VATE program.
The FDA has approved vadadustat (Vafseo) from Akebia Therapeutics to treat anemia due to chronic kidney disease (CKD) in adult patients who have been receiving dialysis for at least 3 months, the pharmaceutical company announced in a release.1
The approval of vadadustat was based on data from the INNO2VATE program / Crystal Light - stock.adobe.com
The approval of vadadustat was based on data from the INNO2VATE (NCT02865850) program, which consisted of 2 phase 3 trials. Vadadustat reached both the primary and secondary endpoints, demonstrating its efficacy and cardiovascular safety. The results from the INNO2VATE program were published in the New England Journal of Medicine.2
Trial Name: Efficacy and Safety Study to Evaluate Vadadustat for the Correction or Maintenance Treatment of Anemia in Participants With Incident Dialysis-dependent Chronic Kidney Disease (DD-CKD)
ClinicalTrials.gov Identifier: NCT02865850
Sponsor: Akebia Therapeutics
Summary: A multicenter, randomized, open-label, active-controlled Phase 3 study for the correction or maintenance treatment of anemia in participants with incident dialysis-dependent chronic kidney disease (DD-CKD).
"With the approval of Vafseo in the US, we're proud to deliver an alternative treatment option for the hundreds of thousands of Americans on dialysis who are diagnosed with anemia due to CKD," John P. Butler, CEO of Akebia, said in a release.1 "At Akebia we are committed to kidney patients, a dedication that has driven our team to achieve this milestone. We believe this commitment uniquely positions the company to execute a successful launch designed to drive toward a potential new oral standard of care for dialysis patients."
The INNO2VATE program included 2 randomized, open-label, noninferiority phase 3 trials to evaluate the safety and efficacy of vadadustat compared with darbepoetin alfa in patients with anemia and incident or prevalent dialysis-dependent CKD. The study cohort included a total of 3923 adult patients, of which 369 were in the incident trial and 3554 were in the prevalent trial.
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The primary and secondary efficacy end points were mean change in hemoglobin from baseline to weeks 24 to 36, and baseline to weeks 40 to 52. The primary safety end point was the first occurrence of a major adverse cardiovascular event—such as a nonfatal myocardial infarction or a nonfatal stroke—assessed in a time-to-event analysis across the trials.
The studies found the first major adverse cardiovascular event occurred in 355 patients in the vadadustat group and in 377 patients in the darbepoetin alfa group. The mean differences in the change in hemoglobin concentration between the groups were −0.31 g per deciliter at weeks 24 to 36 and −0.07 g per deciliter at weeks 40 to 52 in the incident trial. In the prevalent trial, mean differences in the change in hemoglobin concentration was −0.17 g per deciliter and −0.18 g per deciliter.
Additionally, the incidence of serious adverse events was 49.7% in the vadadustat group in the incident trial and 55% in the prevalent trial. The incidences in the darbepoetin alfa group were 56.5% and 58.3%, respectively.
In the release, Akebia said that it intends to commercialize vadadustat in the US with a launch strategy aimed at making the medication the new oral standard of care for adult patients on dialysis.
"We are tremendously grateful for the patients, physicians, investigators, and site coordinators who participated in our clinical trials that led to this important approval,” Butler said.1 “This milestone is the culmination of years of perseverance by Akebia employees and partners committed to bettering the lives of people impacted by kidney disease."
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