AKBA - FDA Approves Akebia's Vafseo (vadadustat) Tablets for the Treatment of Anemia due to chronic kidney disease in Adult Patients on Dialysis
2024-03-28 07:21:49 ET
DENVER, Colo., Mar 28, 2024 ( 247marketnews.com )- Akebia Therapeutics, Inc. (NASDAQ: AKBA ) announced, last night, that the U.S. Food and Drug Administration approved Vafseo (vadadustat) Tablets, which is now approved in 37 countries, for the treatment of anemia due to chronic kidney disease (CKD) in adults receiving dialysis for at least three 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 CKD,” said John P. Butler, Chief Executive Officer of Akebia. “At Akebia we are committed to kidney patients, a dedication that has driven our team to achieve this milestone. We believe this commitment uniquely positions the company to execute a successful launch designed to drive toward a potential new oral standard of care for dialysis patients.”
“Patients receiving maintenance dialysis would benefit from additional therapeutic options that can effectively increase and maintain hemoglobin concentrations within guideline-recommended target ranges,” said Glenn M. Chertow, M.D., M.P.H., Professor of Medicine, Division of Nephrology at Stanford University and Co-Chair of the independent Executive Steering Committee for PRO 2 TECT and INNO 2 VATE, the global Phase 3 clinical development programs for Vafseo.
Lori Hartwell, who has had kidney disease since she was a young child, is the Founder and President of the Renal Support Network. She expressed her support of this new therapy for adults with anemia due to chronic kidney disease on dialysis by stating, “Anemia is a debilitating condition that significantly impacts our daily lives. It is promising to see the introduction of innovative treatment options for people fighting anemia.”
Butler added, “We are tremendously grateful for the patients, physicians, investigators, and site coordinators who participated in our clinical trials that led to this important approval. 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.”
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FDA Approves Akebia’s Vafseo (vadadustat) Tablets for the Treatment of Anemia due to chronic kidney disease in Adult Patients on Dialysis