Business
Akebia Therapeutics Reports First Quarter 2023 Financial Results and Recent Business Highlights
Akebia to host conference call on May 8 at 8:30 a.m. ET Announced vadadustat is now approved in 32 countries following European Commission marketing
About this update from Akebia Therapeutics, Inc.
[{"type":"text","content":"Akebia to host conference call on May 8 at 8:30 a.m. ET \nAnnounced vadadustat is now approved in 32 countries following European Commission marketing authorizationExpects a response to Formal Dispute Resolution from FDA within next 30 daysReleased positive top-line results from vadadustat alternative dosing studyReports Auryxia® (ferric citrate) net product revenue of $34.8M for Q1 2023Affirms 2023 Auryxia net product revenue guidance at $175-$180MCAMBRIDGE, Mass., May 8, 2023 /PRNewswire/ -- Akebia Therapeutics®, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today reported financial results for the first quarter ended March 31, 2023 and provided business highlights.\n\n \n \n \n \n \n \n\n \n\"Approval of Vafseo™ (vadadustat) by the European Commission is a significant milestone for us and for dialysis patients in Europe with anemia due to chronic kidney disease,\" said John P. Butler, Chief Executive Officer of Akebia. \"This is an important step as we continue to deliver on our commitment to better the lives of people with kidney disease. Now we are working to complete a partnership to launch Vafseo in Europe, and we are eager to conclude our appeal process with the FDA.\"\nIn April, the European Commission granted marketing authorization for Vafseo (vadadustat), for the treatment of symptomatic anemia associated with chronic kidney disease (CKD) in adults on chronic maintenance dialysis. Akebia plans to select a partner to commercialize Vafseo in Europe. Vadadustat is now approved in 32 countries. Akebia also expects a regulatory opinion on vadadustat in the United Kingdom, Switzerland and Australia over the course of this year.\nIn the U.S., Akebia has continued to engage with the Office of New Drugs on its Formal Dispute Resolution regarding vadadustat. Dr. Stein, the deciding authority on the appeal, indicated he has completed his internal discussions, and the company expects a response within the next 30 days.\nAkebia also recently reported positive top-line results from FO2CUS, a study evaluating the efficacy and safety of vadadustat in hemodialysis patients who were converted from a long-acting erythropoiesis-stimulating agent (ESA) to three times weekly oral vadadustat dosing for the maintenance treatment of anemia. The data demonstrated th...