After facing significant setbacks, including disappointment, a partnership setback, and an FDA dispute, Akebia Therapeutics has regrouped and is poised for a renewed attempt at securing approval for vadadustat, its treatment for anemia due to chronic kidney disease in adult patients on dialysis.
Akebia has outlined its strategy to resubmit the vadadustat application to the FDA by the end of the third quarter of this year. Following the resubmission, the company anticipates the FDA to provide an approval decision date that will be set six months from the submission date. The company reported a constructive discussion with the FDA regarding this resubmission plan last month.
The initial setback occurred in March 2022 when Akebia received a complete response letter from the FDA, citing safety concerns related to cardiovascular risks and liver injuries associated with vadadustat.
Despite this setback, vadadustat has gained approval in 34 countries outside the United States, with the drug marketed under the name Vafseo in Japan and approved by the European Commission under the European brand.
“We’re extremely pleased the EC has approved Vafseo, an important milestone for Akebia but even more impactful for the hundreds of thousands of Europeans diagnosed with anaemia associated with CKD on dialysis. We believe patients receiving chronic maintenance dialysis would benefit from additional therapeutic options. With approval, we’re eager to select a European partner who can quickly bring Vafseo to those patients.”
– John P. Butler, Chief Executive Officer of Akebia
Vadadustat belongs to the class of drugs known as hypoxia-inducible factor–prolyl hydroxylase inhibitors (HIF-PHI). While initially seen as a potential alternative to erythropoiesis-stimulating agents (ESAs), concerns over safety have impacted the trajectory of this drug class at the FDA. In February, GSK achieved the first FDA approval within this class for Jesduvroq, limited to dialysis patients.
The rejection of vadadustat last year was a significant blow for Akebia. Additionally, its partner Otsuka decided to terminate licensing agreements covering vadadustat for chronic kidney disease anemia across various regions, further complicating matters.
Should the FDA reconsider its stance and grant approval for vadadustat in dialysis patients, Akebia intends to market the drug through its existing partnership with CSL Vifor.
Akebia’s journey with vadadustat illustrates the challenges and determination often involved in bringing innovative treatments to market, with each regulatory hurdle representing a new opportunity for advancement.
