Akebia Therapeutics is gearing up to launch Vafseo (vadadustat) for the treatment of anemia in dialysis patients by January 2025, following its FDA approval earlier this year. Simultaneously, the company is strategizing to re-open discussions with the FDA concerning the potential use of Vafseo in patients with chronic kidney disease (CKD) who are not yet on dialysis.
The initial FDA rejection in 2022 for the pre-dialysis population was based on concerns about a higher incidence of major adverse cardiovascular events (MACE) compared to erythropoiesis-stimulating agents (ESAs). However, Akebia is now preparing to present additional data from its Phase 3 PRO2TECT trial to address these concerns and highlight the unmet medical need in this patient group.
Addressing Unmet Needs in Pre-Dialysis Anemia
According to Nicholas Grund, chief commercial officer for Akebia, less than 25% of non-dialysis patients are currently treated for anemia, underscoring the significant market potential. CEO John P. Butler emphasized the FDA's acknowledgement of an "unmet medical need" for anemia treatment in CKD patients, viewing it as a positive sign for future discussions.
Butler noted that even among stage 4 and 5 CKD patients with an eGFR below 30 mL/min/1.73m2, where anemia becomes more pronounced, approximately half a million individuals could benefit from an oral anemia treatment like Vafseo.
Strategy for FDA Engagement
Akebia anticipates receiving feedback from the FDA by the end of the year regarding the requirements for pursuing approval in the pre-dialysis population. Butler acknowledged the need for new clinical data and expressed the company's commitment to generating the necessary evidence.
Vafseo's Potential in Dialysis Patients
Butler believes Vafseo has the potential to become a standard of care for anemia management, particularly in home dialysis patients. He pointed out that a once-daily oral product could be more convenient for these patients compared to injectable ESAs, reducing the need for frequent clinic visits. Vafseo may also benefit patients who require high doses of ESAs to maintain target hemoglobin levels, as higher ESA doses are associated with increased MACE risk. "Twenty-five percent of patients are not in the target range for hemoglobin. A lot of those patients are on high doses of ESAs, and we know that the higher the dose, the higher the MACE risk," Butler said.
Financial Overview
Akebia's total revenues for the second quarter of 2024 were $43.6 million, a decrease from $56.4 million in the same period last year. This decrease was primarily due to a reduction in license and collaboration revenue. Net product revenues were $41.2 million, compared to $42.2 million in the second quarter of 2023. The company has set the wholesale acquisition cost for Vafseo at $1,278 for a 30-day supply at the labeled starting dose, or approximately $15,500 per year.
