Akebia receives FDA approval for anemia drug Vafseo
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Key takeaways:
- The FDA has approved the anemia drug Vafseo for adults with dialysis-dependent chronic kidney disease.
- Akebia said the drug is approved for use in 37 other countries.
Akebia Therapeutics Inc. has received FDA approval for its oral anemia drug Vafseo for treating anemia in adults with end-stage kidney disease on dialysis for at least 3 months.
“With the approval of Vafseo in the U.S., 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 [chronic kidney disease] CKD,” John P. Butler, CEO of Akebia, said in a press release.
FDA approval of Vafseo (vadadustat) comes after the agency turned down the first new drug application by Akebia for vadadustat in March 2022, as the FDA cited concerns over vascular access complications and liver toxicity. Akebia resubmitted the NDA in October 2023.
“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,” Butler said in the release.
Vafseo is a once-daily oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor that activates the physiologic response to hypoxia to stimulate endogenous production of erythropoietin, increasing hemoglobin and red blood cell production to manage anemia. “Patients receiving maintenance dialysis would benefit from additional therapeutic options that can effectively increase and maintain hemoglobin concentrations within guideline-recommended target ranges,” Glenn M. Chertow, MD, MPH, a professor of medicine in the division of nephrology at Stanford University and co-chair of the independent executive steering committee for PRO2TECT and INNO2VATE, the global phase 3 clinical development programs for Vafseo, said in the release.
Vafseo is the second oral HIF-PH inhibitor approved for use in the United States for patients with ESKD on dialysis. The FDA approved Jesduvroq (daprodustat), sold by GlaxoSmithKline, in February 2023 for treatment of anemia in patients with CKD who are on dialysis.
Reference:
Akebia receives FDA acceptance of resubmission to NDA of vadadustat for the treatment of anemia due to chronic kidney disease. https://ir.akebia.com/news-releases/news-release-details/akebia-receives-fda-acceptance-resubmission-nda-vadadustat. Published Oct. 25, 2023. Accessed Oct. 25, 2023.
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