Vadadustat clinical data on display for nephrologist and healthcare providers in advance of U.S. market availability expected in January 2025
CAMBRIDGE, Mass., Oct. 15, 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 it will present data at the American Society of Nephrology Kidney Week 2024 (ASN Kidney Week), which will take place in San Diego, CA from October 24-27.
Akebia-supported posters will be presented at ASN Kidney Week on Thursday, October 24 from 10:00 AM – 12:00 PM PDT. Abstracts are available here. ASN Kidney Week attendees can also visit Akebia at Booth #2202 in the Exhibit Hall.
Of note, six posters present clinical data on vadadustat, Akebia's oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor, including post-marketing surveillance of use in Japan where vadadustat is approved for use in dialysis and non-dialysis dependent patients. In March 2024, Vafseo® (vadadustat) was approved by the U.S. Food and Drug Administration for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three months. In parallel with its ongoing commercial launch of Vafseo and expected product U.S. market availability in January 2025, Akebia continues to engage with the nephrology community by sharing important data to further scientific exchange and dialogue about Vafseo and anemia of CKD.
All Akebia-supported posters to be presented at ASN Kidney Week 2024:
About Akebia Therapeutics
Akebia 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.
About 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.
INDICATION
VAFSEO 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.
Limitations of Use
IMPORTANT SAFETY INFORMATION about VAFSEO (vadadustat) tablets
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). 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. |
CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS
ADVERSE REACTIONS
DRUG INTERACTIONS
USE IN SPECIFIC POPULATIONS
Please note that this information is not comprehensive. Please click here for the Full Prescribing Information, including BOXED WARNING and Medication Guide.
Forward-Looking Statements
Statements 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; and Akebia's plans with respect to its ongoing commercial launch of Vafseo, including that Akebia's continued engagement with the nephrology community by sharing important data will further scientific exchange and dialogue about Vafseo and anemia of CKD. 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; the potential demand and market potential and acceptance of, as well as coverage and reimbursement related to, Auryxia® and Vafseo, including estimates regarding the potential market opportunity; the competitive landscape for Auryxia and Vafseo, including potential generic entrants; the ability of Akebia to attract and retain qualified personnel; Akebia's ability to implement cost avoidance measures and reduce operating expenses; 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; manufacturing, supply chain and quality matters and any recalls, write-downs, impairments or other related consequences or potential consequences; 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 June 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.
Akebia Therapeutics® and Vafseo® are registered trademarks of Akebia Therapeutics, Inc. and its affiliates.
Akebia Therapeutics Contact
Mercedes Carrasco
mcarrasco@akebia.com
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SOURCE Akebia Therapeutics, Inc.