ST. GALLEN, SWITZERLAND, March 28, 2024 /PRNewswire/ -- CSL Vifor is pleased that its partner Akebia Therapeutics, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved Vafseo (vadadustat) tablets for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three months. Vafseo is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) developed by Akebia.
U.S. FDA approves Akebia`s anemia drug
CAMBRIDGE, Mass., March 27, 2024 /PRNewswire/ -- Akebia Therapeutics®, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced that the U.S. Food and Drug Administration (FDA) has approved Vafseo® (vadadustat) Tablets for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three months. 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 to manage anemia. Vafseo is now approved in 37 countries.
CAMBRIDGE, Mass., Sept. 28, 2023 /PRNewswire/ -- Akebia Therapeutics®, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced it has resubmitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for vadadustat, Akebia's investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor, for the treatment of anemia due to chronic kidney disease (CKD) in adult patients on dialysis. Vadadustat is currently approved for use in 35 countries.
CAMBRIDGE, Mass., Sept. 26, 2023 /PRNewswire/ -- Akebia Therapeutics®, Inc. (Nasdaq: AKBA) today announced that Australia's Therapeutic Goods Administration (TGA) has granted approval for Vafseo® (vadadustat), an oral hypoxia-inducible factor prolyl hydroxylase inhibitor for the treatment of anemia associated with chronic kidney disease (CKD) in adults on chronic maintenance dialysis.
After the “extreme disappointment” of vadadustat’s anemia snub in March 2022—plus a partnership gone awry and a formal dispute with the FDA—Akebia Therapeutics has dusted itself off and readied for a second bid at approval.
CAMBRIDGE, Mass., July 18, 2023 /PRNewswire/ -- Akebia Therapeutics®, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced that Akebia completed an End of Dispute Type A meeting with the U.S. Food and Drug Administration (FDA) to discuss Akebia's forthcoming resubmission of its New Drug Application (NDA) for vadadustat as a treatment for anemia due to chronic kidney disease (CKD) in adult patients on dialysis.
CAMBRIDGE, Mass., June 20, 2023 /PRNewswire/ -- Akebia Therapeutics®, Inc. (Nasdaq: AKBA) today announced that the Swiss Agency for Therapeutic Products (Swissmedic) has granted marketing authorization for Vafseo® (vadadustat), an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor for the treatment of symptomatic anemia associated with chronic kidney disease (CKD) in adults on chronic maintenance dialysis.
Akebia`s Vafseo (Vadadustat) Receives Approval in the Europe
The FDA still won’t approve Akebia’s drug for anemia due to chronic kidney disease, but the agency is apparently keeping the door open to a resubmission — without asking for new clinical data for vadadustat.