With FDA clearance, Akebia’s Vafseo finally has a chance to compete in the US chronic renal disease market

Despite a setback when the FDA denied its first effort at clearance for Vafseo, an oral therapy for chronic kidney disease (CKD) anemia, two years ago, Akebia remained unwavering in its trust in the product. But the business just achieved a big milestone when it got the FDA’s long-awaited clearance for Vafseo. With this clearance, patients with CKD-associated anemia who have received dialysis for at least three months can take Vafseo. This creates a competitive market environment as Akebia and GSK compete head-to-head.
After Akebia provided further safety data from Japanese patients—where Vafseo has been on the market since 2020—the permission was granted. The FDA’s prior concerns regarding possible liver damage were addressed by these findings, which prompted a review of the drug’s safety profile.

To secure its continued existence, Akebia made significant adjustments in the last few years, including halving its personnel and concentrating on Auryxia, its main commercial asset, for CKD management. In his account of Vafseo’s path, CEO John Butler emphasized the FDA’s initial concerns about drug-induced liver harm, which Akebia refuted. The business launched a formal dispute resolution procedure to contest the FDA’s ruling since it was so sure of its position.
In addition to data from clinical trials, Akebia also used real-world data from Japan, where Vafseo’s commercialization was overseen by Mitsubishi Tanabe Pharma. Akebia’s confidence in Vafseo’s safety was reinforced by the extensive post-marketing surveillance conducted in Japan, which did not uncover any serious cases of drug-induced liver impairment.
When compared to conventional treatments, Vafseo stands out as a novel method of treating anemia. The hypoxia-inducible factor–prolyl hydroxylase inhibitor (HIF-PHI) induces the bone marrow to create more red blood cells by simulating high-altitude circumstances.
Vafseo would have been a groundbreaking treatment in its class despite the initial delay. Nevertheless, GSK’s Jesduvroq, which targets the dialysis-dependent patient group, asserted that title after receiving approval in February 2023. The competitive environment was further impacted by GSK’s choice not to pursue commercialization in Europe.
Akebia hopes to broaden its scope in the future, even if the permission is initially restricted to patients who are reliant on dialysis. Preclinical drugs for various ailments including acute renal damage and retinopathy of prematurity are another area of emphasis for the firm as it works to improve its pipeline.

Though Akebia is experiencing layoffs and financial difficulties, the company remains upbeat about its future, particularly now that it has established strategic alliances to efficiently market Vafseo. With Vafseo, the business hopes to replace traditional injectable therapies with an oral option for dialysis patients.
Akebia is ready for expansion and innovation in the CKD management industry and beyond, having received authorization in several countries and maintaining a clear strategic orientation.