Akebia Therapeutics Reports Second Quarter 2024 Financial Results and Recent Business Highlights
CAMBRIDGE, Mass., June 29, 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 topline results from IMPACT, a Phase 4 collaborative study investigating the impact of Auryxia® (ferric citrate), when used as the primary phosphate-lowering therapy, on the utilization of erythropoiesis-stimulating agent (ESA) and intravenous (IV) iron as well as on laboratory parameters indicative of phosphate and anemia management compared to the standard of care (SOC) in adult patients with chronic kidney disease (CKD) on dialysis. Auryxia is approved for the control of serum phosphorus levels in adult patients with chronic kidney disease on dialysis and for the treatment of iron deficiency anemia in adult patients with chronic kidney disease not on dialysis.
Enforcement Report - Week of February 24, 2021
Enforcement Report - Week of December 30, 2020
Enforcement Report - Week of July 22, 2020
CAMBRIDGE, Mass., June 10, 2020 /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 data from an investigational clinical research study on different dose regimens of ferric citrate for the treatment of iron deficiency anemia was presented at the 57th ERA-EDTA Virtual Congress, which took place June 6-9, 2020. For more information about the virtual event, visit: https://www.era-edta.org/en/virtualcongress2020/.
Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company focused on the development and commercialization of therapeutics for people living with kidney disease, announced today that its collaboration partner, Japan Tobacco, Inc. (JT), has filed a supplemental New Drug Application (NDA) with the Pharmaceuticals and Medical Devices Agency (PMDA) seeking an additional indication for Riona® Tablets 250mg (generic name in Japan: ferric citrate hydrate) to treat adult patients with iron deficiency anemia (IDA) in Japan. JT and its subsidiary, Torii Pharmaceutical Co., Ltd. (Torii), made a public announcement, which is available here: https://www.torii.co.jp/en/release/2020/20200515_E1.pdf.
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Akebia Therapeutics, Inc. (Nasdaq: AKBA), a fully integrated biopharmaceutical company focused on bettering the lives of people impacted by kidney disease, today filed a complaint in federal district court against the Centers for Medicare & Medicaid Services (CMS) and the U.S. Department of Health and Human Services (HHS). The lawsuit challenges a September 2018 decision by CMS that rescinded Medicare Part D coverage of Auryxia® (ferric citrate), Akebia’s FDA-approved drug, when used for the treatment of iron deficiency anemia (IDA) in adult patients with chronic kidney disease (CKD) not on dialysis (the IDA Indication). The legal action also seeks to reverse a related decision by CMS that imposed a prior authorization requirement for Auryxia when used for the control of serum phosphorus levels in adult patients with CKD on dialysis (the Hyperphosphatemia Indication).
Auryxia (Ferric Citrate) : Keryx Biopharma vs. Mylan Pharma
Auryxia (Ferric Citrate) : Keryx Biopharmaceuticals vs. Teva Pharmaceuticals