Business
Akebia Reports First Quarter 2021 Financial Results and Highlights Recent Company Milestones
- Vadadustat New Drug Application (NDA) submitted to the U.S. Food and Drug Administration (FDA) - Results of global Phase 3 programs for vadadustat published
About this update from Akebia Therapeutics, Inc.
[{"type":"text","content":"- Vadadustat New Drug Application (NDA) submitted to the U.S. Food and Drug Administration (FDA)\n - Results of global Phase 3 programs for vadadustat published in New England Journal of Medicine\n - Conference call today at 9:00 a.m. ET\n\n\n CAMBRIDGE, Mass., May 10, 2021 /PRNewswire/ -- Akebia Therapeutics®, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose of bettering the lives of people impacted by kidney disease, today reported financial results for the first quarter ended March 31, 2021 and highlighted recent corporate milestones. The Company will host a conference call today, Monday, May 10, 2021, at 9:00 a.m. Eastern Time.\n\n \n \n \n \n \n \n\n \n\"Akebia is off to a great start in 2021, building positive momentum with solid execution on strategic priorities that set the stage for an exciting year. Most importantly, we submitted the vadadustat NDA to the FDA, a significant milestone for Akebia and our partner, Otsuka Pharmaceutical Co. Ltd. We are also very proud that the New England Journal of Medicine recently published the results from both INNO2VATE and PRO2TECT, the global Phase 3 programs for vadadustat. We believe these publications reinforce the scientific rigor and quality of the vadadustat clinical development program, and we are pleased with early feedback from the medical community,\" stated John P. Butler, Chief Executive Officer of Akebia. \"We believe this progress positions us well to continue advancing vadadustat with the goal of bringing this novel therapeutic to patients as quickly as possible, subject to regulatory approval. We remain confident in the clarity and quality of our data, and we look forward to engaging with the FDA on our NDA. In addition, we are working with Otsuka on the preparation of a Marketing Authorization Application (MAA) for vadadustat for submission to the European Medicines Agency (EMA), expected this year.\" \nRecent Business Highlights: \nIn April, the New England Journal of Medicine (NEJM) published the results of Akebia's global Phase 3 program for vadadustat, which consisted of two programs that evaluated the efficacy and safety of vadadustat versus darbepoetin alfa for the treatment of anemia due to CKD in adult patients on dialysis (INNO2VATE) and not on dialysis (PRO2TECT). In March, Akebia submitted an NDA to the FDA for vadadustat for the treatmen...