This section highlights FDA-related milestones and regulatory updates for drugs developed by Akebia Therapeutics (AKBA).
Over the past two years, Akebia Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Vadadustat and XOANACYL. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Vadadustat - FDA Regulatory Timeline and Events
Vadadustat is a drug developed by Akebia Therapeutics for the following indication: Anemia due to chronic kidney disease (CKD).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Vadadustat
- Announced Date:
- June 4, 2025
- Indication:
- Anemia due to chronic kidney disease (CKD)
Announcement
- Akebia Therapeutics®, announced that the Journal of the American Society of Nephrology (JASN) has published pre-specified analyses for the U.S. and non-U.S. patient subgroups from the vadadustat global phase 3 clinical program, which included two trials in patients with dialysis-dependent chronic kidney disease (DD-CKD; INNO2VATE) and two trials in patients with non–dialysis-dependent CKD (NDD-CKD; PRO2TECT).
AI Summary
Akebia Therapeutics® announced that the Journal of the American Society of Nephrology has published pre-specified analyses from its vadadustat global phase 3 clinical program. The program included two trials for dialysis-dependent chronic kidney disease (DD-CKD; INNO2VATE) and two trials for non–dialysis-dependent CKD (NDD-CKD; PRO2TECT). The analyses looked at both U.S. and non-U.S. patient subgroups, comparing the safety and efficacy of vadadustat with darbepoetin alfa. For U.S. patients with DD-CKD, the results showed similar safety and efficacy outcomes for both treatments. In patients with NDD-CKD, while safety and efficacy were also comparable, there was a higher risk for major adverse cardiovascular events with vadadustat outside the United States. These findings highlight how regional differences may influence trial outcomes, providing key insights for physicians treating CKD-related anemia.
Read Announcement- Drug:
- Vadadustat
- Announced Date:
- March 13, 2025
- Indication:
- Anemia due to chronic kidney disease (CKD)
Announcement
Akebia Therapeutics® recent business highlights.
AI Summary
Akebia Therapeutics recently announced strong early results for its U.S. launch of Vafseo (vadadustat) for treating anemia in chronic kidney disease patients on dialysis. The company expects net product revenues of approximately $10-$11 million in the first quarter of 2025. Vafseo began shipping on January 9, 2025, and has already received orders from three of the top four U.S. dialysis organizations. Over 500 prescribers have issued prescriptions, with the average prescriber writing about eight prescriptions.
CEO John P. Butler expressed confidence in Vafseo becoming the new standard of care for dialysis patients. Akebia is also planning to expand Vafseo’s use to non-dialysis CKD patients by meeting with the FDA to discuss the Phase 3 VALOR study protocol, aiming to initiate the trial later this year. The company’s current cash resources and cash from operations are expected to support its operating plan for at least two years.
Read Announcement- Drug:
- Vadadustat
- Announced Date:
- December 3, 2024
- Indication:
- Anemia due to chronic kidney disease (CKD)
Announcement
Akebia Therapeutics®, Inc. announced that in late November U.S. Renal Care (USRC) enrolled the first patient in its Vafseo® (vadadustat) Outcomes In-Center Experience (VOICE) collaborative trial.
AI Summary
Akebia Therapeutics® recently announced that in late November, U.S. Renal Care (USRC) enrolled the first patient in the Vafseo® (vadadustat) Outcomes In-Center Experience (VOICE) collaborative trial. This study is designed to evaluate the safety and effectiveness of Vafseo when it is administered three times a week, aligning with patients’ existing dialysis schedules. The trial aims to compare Vafseo treatment with current standard-of-care erythropoiesis-stimulating agents by assessing outcomes such as all-cause mortality and hospitalization rates. Approximately 2,200 patients are expected to be enrolled, with the study concluding about 18 months after the last patient is randomized. The trial is a key step in exploring additional benefits for chronic kidney disease patients with anemia and is part of plans leading up to the anticipated U.S. market launch of Vafseo in January 2025.
Read Announcement- Drug:
- Vadadustat
- Announced Date:
- October 10, 2024
- Indication:
- Anemia due to chronic kidney disease (CKD)
Announcement
Akebia Therapeutics®, Inc announced that the Center for Medicare & Medicaid Services (CMS) has determined that Vafseo® (vadadustat) meets the criteria for the Transitional Drug Add-On Payment Adjustment (TDAPA) in the anemia management end-stage renal disease (ESRD) prospective payment system functional category, beginning on January 1, 2025.
AI Summary
Akebia Therapeutics® announced that the Center for Medicare & Medicaid Services (CMS) has approved its drug Vafseo® (vadadustat) for the Transitional Drug Add-On Payment Adjustment (TDAPA). This means that starting January 1, 2025, Vafseo will be eligible for an extra two years of reimbursement beyond the standard ESRD bundled rate. This additional payment is designed to help dialysis organizations incorporate Vafseo into their treatment options for anemia management in patients with end-stage renal disease.
A HCPCS code has also been assigned to Vafseo to simplify the billing process for dialysis centers serving Medicare enrollees. This milestone is a key part of Akebia's strategy to bring innovative treatments to market and supports efforts to help dialysis providers offer improved care to patients with kidney disease.
Read Announcement- Drug:
- Vadadustat
- Announced Date:
- September 5, 2024
- Indication:
- Anemia due to chronic kidney disease (CKD)
Announcement
Akebia Therapeutics®, Inc. announced plans to begin a collaborative clinical trial of recently approved Vafseo. The first patient in this trial is expected to be enrolled this year.
AI Summary
Akebia Therapeutics, Inc. has announced plans to launch a collaborative clinical trial for Vafseo, a newly approved treatment for anemia in chronic kidney disease patients undergoing dialysis. The study, conducted in partnership with U.S. Renal Care, will enroll about 2,200 patients who will be randomly assigned to receive either Vafseo tablets or the standard erythropoiesis-stimulating agents. The trial is designed to investigate key outcomes, including overall mortality and hospitalization rates, while also building a robust body of real-world evidence regarding the treatment’s benefits. Notably, the first patient is expected to be enrolled later this year. This initiative aims to further explore Vafseo’s safety and its potential to become an important, orally administered option for managing anemia in dialysis patients.
Read Announcement- Drug:
- Vadadustat
- Announced Date:
- July 11, 2024
- Indication:
- Anemia due to chronic kidney disease (CKD)
Announcement
Akebia Therapeutics®, announced key updates pertaining to the commercial launch of Vafseo® (vadadustat) Tablets. Akebia will host an investor conference call at 8:00 a.m. ET on Thursday, July 11, 2024.
AI Summary
Akebia Therapeutics® provided key updates on the commercial launch of Vafseo® (vadadustat) Tablets. The company announced that it has regained full rights to market Vafseo in the U.S. after finalizing a royalty-based termination agreement with CSL Vifor. This move is designed to streamline operations, enhance economic performance, and accelerate contracting discussions with dialysis organizations, including Fresenius Kidney Care and select third-party providers.
In addition, Akebia revealed that it has set the wholesale acquisition cost (WAC) for Vafseo at $1,278 for a 30-day supply and submitted its TDAPA application in June 2024. The approval process is expected to progress with designation scheduled for January 1, 2025. The company also announced an investor conference call to discuss these commercial launch updates on Thursday, July 11, 2024, at 8:00 a.m. ET.
Read Announcement
XOANACYL - FDA Regulatory Timeline and Events
XOANACYL is a drug developed by Akebia Therapeutics for the following indication: Oral Therapy for Chronic Kidney Disease.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- XOANACYL
- Announced Date:
- April 3, 2025
- Indication:
- Oral Therapy for Chronic Kidney Disease
Announcement
Akebia Therapeutics®, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the European Commission (EC) to approve XOANACYL® (Ferric Citrate as Coordination Complex) for the treatment of concomitant elevated serum phosphorous and iron deficiency in adult patients with chronic kidney disease (CKD).
AI Summary
Akebia Therapeutics® announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has provided a positive opinion recommending that the European Commission (EC) approve XOANACYL® (Ferric Citrate as Coordination Complex). This treatment is aimed at adult patients with chronic kidney disease (CKD) who suffer from both elevated serum phosphorous and iron deficiency. The positive CHMP recommendation represents an important step forward in making a new option available to address these dual complications in CKD patients. Averoa, which holds the rights to develop and market the treatment in the European Economic Area and select countries in Europe and the Middle East, will now work toward obtaining final approval from the EC. A final decision from the EC is expected in about two months.
Read Announcement
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