Vadadustat Alternative Dosing Study Results Published in the American Journal of Kidney Disease

PR Newswire11-14

Akebia continues to publish important results of FO2CUS trial to further physicians' understanding of Vafseo® (vadadustat) CAMBRIDGE, Mass., Nov. 14, 2024 /PRNewswire/ -- Akebia Therapeutics®, Inc. (...

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CAMBRIDGE, Mass., Nov. 14, 2024 /PRNewswire/ -- Akebia Therapeutics, Inc. , a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced that the American Journal of Kidney Disease has published the results of FO2CUS, an open-label study evaluating the efficacy and safety of vadadustat, an oral hypoxia-inducible factor prolyl hydroxylase  inhibitor, in hemodialysis patients who were converted from a long-acting erythropoiesis-stimulating agent  to three times weekly oral vadadustat dosing for the maintenance treatment of anemia.\"The publication of the FO2CUS data in the American Journal of Kidney Disease is an important milestone and demonstrates Akebia's commitment to both research and to continuing to publish findings from its Vafseo trials,\" said Steven K. Burke, M.D., Senior Vice President, Research & Development an","collect":0,"end_time":0,"defaultTopTitle":"yahoo.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"BK4161":"工业机械","LU2065731478.USD":"ALLSPRING (LUX) WORLDWIDE FUND - SMALL CAP INNOVA \"I\" (USD) ACC","BK4117":"多元化保险","BK4183":"个人用品","MI":"NFT Limited","MACE":"Mace Security International, Inc.","BK4139":"生物科技","BK4077":"互动媒体与服务","AFG":"美国金融集团有限公司","BK4107":"财产与意外伤害保险","BK4157":"电子设备和仪器","RBC":"RBC轴承","AKBA":"Akebia Therapeutics, Inc.","IE00B64QTZ34.USD":"NEUBERGER BERMAN US SMALL CAP \"A\" (USD) ACC","IE00BLDYK493.USD":"NEUBERGER BERMAN US SMALL CAP \"A\" (USD) INC"},"translate_title":"Vadadustat替代给药研究结果发表于《美国肾脏病杂志》","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"AFG":1,"MACE":1,"MI":1,"RBC":1,"AKBA":0.9},"content_text":"Akebia continues to publish important results of FO2CUS trial to further physicians' understanding of Vafseo® (vadadustat) \nCAMBRIDGE, Mass., Nov. 14, 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 American Journal of Kidney Disease has published the results of FO2CUS, an open-label study evaluating the efficacy and safety of vadadustat, an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor, 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.\n\n  \n\nThe article titled, \"Vadadustat Three Times Weekly in Patients With Anemia Due to Dialysis-Dependent CKD,\" is available here.\nVafseo® (vadadustat) was approved by the U.S. Food and Drug Administration in March 2024 for the treatment of anemia due to chronic kidney disease in adults who have been receiving dialysis for at least three months. Vafseo is approved for once-daily oral administration and is expected to be available in the U.S. in January 2025.\n\"The publication of the FO2CUS data in the American Journal of Kidney Disease is an important milestone and demonstrates Akebia's commitment to both research and to continuing to publish findings from its Vafseo trials,\" said Steven K. Burke, M.D., Senior Vice President, Research & Development and Chief Medical Officer of Akebia.\nFO2CUS was an open-label, active-controlled, sponsor-blinded study that evaluated 456 hemodialysis patients who were randomized (1:1:1) into vadadustat 600mg, vadadustat 900mg, or a long-acting ESA (Mircera®) treatment arms. The primary efficacy endpoint was the mean change in hemoglobin (Hb) between baseline and the primary evaluation period (weeks 20-26). The secondary efficacy endpoint was the mean change in Hb between baseline and the secondary evaluation period (weeks 46-52). The top-line results of the FO2CUS study are available here.\nFirst published in 1981, the American Journal of Kidney Diseases is the official journal of the National Kidney Foundation. AJKD is recognized worldwide as a leading source of information devoted to clinical nephrology research and practice. Articles selected for publication in AJKD undergo a rigorous peer review and editorial consideration process, including statistical review where appropriate, supporting the journal's goal to communicate important new information in clinical nephrology in a way that strengthens knowledge and helps physicians to provide their patients with the highest standard of care.\nAbout Akebia TherapeuticsAkebia Therapeutics, Inc. is a fully integrated biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease. Akebia was founded in 2007 and is headquartered in Cambridge, Massachusetts. For more information, please visit our website at www.akebia.com, which does not form a part of this release.\nAbout Vafseo® (vadadustat) tablets Vafseo® (vadadustat) tablets is a once-daily oral hypoxia-inducible factor prolyl hydroxylase inhibitor that activates the physiologic response to hypoxia to stimulate endogenous production of erythropoietin, increasing hemoglobin and red blood cell production to manage anemia. Vafseo is approved for use in 37 countries.\nINDICATIONVAFSEO is indicated for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three months.\nLimitations of Use\n\nVAFSEO has not been shown to improve quality of life, fatigue, or patient well-being.\nVAFSEO is not indicated for use:\n   \nAs a substitute for red blood cell transfusions in patients who require immediate correction of anemia.\nIn patients with anemia due to CKD not on dialysis.\n\n\nIMPORTANT SAFETY INFORMATION about VAFSEO (vadadustat) tablets\n\n\n\n\n                WARNING: INCREASED RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS                            THROMBOEMBOLISM, and THROMBOSIS OF VASCULAR ACCESS.VAFSEO increases the risk of thrombotic vascular events, including major adverse cardiovascular events (MACE). Targeting a hemoglobin level greater than 11 g/dL is expected to further increase the risk of death and arterial and venous thrombotic events, as occurs with erythropoietin stimulating agents (ESAs), which also increase erythropoietin levels. No trial has identified a hemoglobin target level, dose of VAFSEO, or dosing strategy that does not increase these risks. Use the lowest dose of VAFSEO sufficient to reduce the need for red blood cell transfusions. \n\n\n\n\nCONTRAINDICATIONS \n\nKnown hypersensitivity to VAFSEO or any of its components\nUncontrolled hypertension\n\nWARNINGS AND PRECAUTIONS \n\nIncreased Risk of Death, Myocardial Infarction (MI), Stroke, Venous Thromboembolism, and Thrombosis of Vascular AccessA rise in hemoglobin (Hb) levels greater than 1 g/dL over 2 weeks can increase these risks. Avoid in patients with a history of MI, cerebrovascular event, or acute coronary syndrome within the 3 months prior to starting VAFSEO. Targeting a Hb level of greater than 11 g/dL is expected to further increase the risk of death and arterial and venous thrombotic events. Use the lowest effective dose to reduce the need for red blood cell (RBC) transfusions. Adhere to dosing and Hb monitoring recommendations to avoid excessive erythropoiesis.\nHepatotoxicityHepatocellular injury attributed to VAFSEO was reported in less than 1% of patients, including one severe case with jaundice. Elevated serum ALT, AST, and bilirubin levels were observed in 1.8%, 1.8%, and 0.3% of CKD patients treated with VAFSEO, respectively. Measure ALT, AST, and bilirubin before treatment and monthly for the first 6 months, then as clinically indicated. Discontinue VAFSEO if ALT or AST is persistently elevated or accompanied by elevated bilirubin. Not recommended in patients with cirrhosis or active, acute liver disease.\nHypertensionWorsening of hypertension was reported in 14% of VAFSEO and 17% of darbepoetin alfa patients. Serious worsening of hypertension was reported in 2.7% of VAFSEO and 3% of darbepoetin alfa patients. Cases of hypertensive crisis, including hypertensive encephalopathy and seizures, have also been reported in patients receiving VAFSEO. Monitor blood pressure. Adjust anti-hypertensive therapy as needed.\nSeizuresSeizures occurred in 1.6% of VAFSEO and 1.6% of darbepoetin alfa patients. Monitor for new-onset seizures, premonitory symptoms, or change in seizure frequency.\nGastrointestinal (GI) ErosionGastric or esophageal erosions occurred in 6.4% of VAFSEO and 5.3% of darbepoetin alfa patients. Serious GI erosions, including GI bleeding and the need for RBC transfusions, were reported in 3.4% of VAFSEO and 3.3% of darbepoetin alfa patients. Consider this risk in patients at increased risk of GI erosion. Advise patients about signs of erosions and GI bleeding and urge them to seek prompt medical care if present.\nSerious Adverse Reactions in Patients with Anemia Due to CKD and Not on Dialysis The safety of VAFSEO has not been established for the treatment of anemia due to CKD in adults not on dialysis and its use is not recommended in this setting. In large clinical trials in adults with anemia of CKD who were not on dialysis, an increased risk of mortality, stroke, MI, serious acute kidney injury, serious hepatic injury, and serious GI erosions was observed in patients treated with VAFSEO compared to darbepoetin alfa.\nMalignancyVAFSEO has not been studied and is not recommended in patients with active malignancies. Malignancies were observed in 2.2% of VAFSEO and 3.0% of darbepoetin alfa patients. No evidence of increased carcinogenicity was observed in animal studies.\n\nADVERSE REACTIONS\n\nThe most common adverse reactions (occurring at ≥ 10%) were hypertension and diarrhea.\n\nDRUG INTERACTIONS\n\nIron supplements and iron-containing phosphate binders: Administer VAFSEO at least 1 hour before products containing iron.\nNon-iron-containing phosphate binders: Administer VAFSEO at least 1 hour before or 2 hours after non-iron-containing phosphate binders.\nBCRP substrates: Monitor for signs of substrate adverse reactions and consider dose reduction.\nStatins: Monitor for statin-related adverse reactions. Limit the daily dose of simvastatin to 20 mg and rosuvastatin to 5 mg.\n\nUSE IN SPECIFIC POPULATIONS\n\nPregnancy: May cause fetal harm.\nLactation: Breastfeeding not recommended until two days after the final dose.\nHepatic Impairment: Not recommended in patients with cirrhosis or active, acute liver disease.\n\nPlease note that this information is not comprehensive. Please click here for the Full Prescribing Information, including BOXED WARNING and Medication Guide. \nForward-Looking StatementsStatements in this press release regarding Akebia Therapeutics, Inc.'s (\"Akebia's\") strategy, plans, prospects, expectations, beliefs, intentions and goals are forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, as amended, and include, but are not limited to, statements regarding:  Akebia's expectations as to the timing of the market availability of Vafseo in the U.S. and Akebia's commitment to both research and to continuing to publish findings from its Vafseo trials. The terms \"intend,\" \"believe,\" \"plan,\" \"goal,\" \"potential,\" \"anticipate, \"estimate,\" \"expect,\" \"future,\" \"will,\" \"continue,\" derivatives of these words, and similar references are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results, performance or experience may differ materially from those expressed or implied by any forward-looking statement as a result of various risks, uncertainties and other factors, including, but not limited to, risks associated with: whether Vafseo will be commercially available when expected; manufacturing, supply chain and quality matters and any recalls, write-downs, impairments or other related consequences or potential consequences; the potential demand and market potential and acceptance of, as well as coverage and reimbursement related to Vafseo; the competitive landscape for Vafseo; the ability of Akebia to attract and retain qualified personnel; decisions made by health authorities, such as the FDA, with respect to regulatory filings; the potential therapeutic benefits, safety profile, and effectiveness of Vafseo; the results of preclinical and clinical research; the direct or indirect impact of the COVID-19 pandemic on the markets and communities in which Akebia and its partners, collaborators, vendors and customers operate; and early termination of any of Akebia's collaborations. Other risks and uncertainties include those identified under the heading \"Risk Factors\" in Akebia's Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, and other filings that Akebia may make with the U.S. Securities and Exchange Commission in the future. These forward-looking statements (except as otherwise noted) speak only as of the date of this press release, and, except as required by law, Akebia does not undertake, and specifically disclaims, any obligation to update any forward-looking statements contained in this press release.\nAkebia Therapeutics® and Vafseo® are registered trademarks of Akebia Therapeutics, Inc. and its affiliates.\nAkebia Therapeutics ContactMercedes Carrascomcarrasco@akebia.com\n View original content to download multimedia:https://www.prnewswire.com/news-releases/vadadustat-alternative-dosing-study-results-published-in-the-american-journal-of-kidney-disease-302304951.html\nSOURCE Akebia Therapeutics, Inc.","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"0","news_tag":"","news_rank":0,"symbols":[],"gpt_button":1},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)","isDev":false,"isTTM":true,"deviceId":"web-server-community-laohu8-v3","version":"4.29.3","shortVersion":"4.29.3","platform":"web","vendor":"web","appName":"ttm","isIOS":false,"isAndroid":false,"isTiger":false,"isTHS":false,"isWeiXin":false,"isWeiXinMini":false,"isWeiBo":false,"isQQ":false,"isBaiduSwan":false,"isBaiduBox":false,"isDingTalk":false,"isToutiao":false,"isOnePlus":false,"isHuaWei":false,"isXiaomi":false,"isXiaomiWebView":false,"isOppo":false,"isVivo":false,"isSamsung":false,"isMobile":false},"href":"/m/news/2483877493"}