VIFOR-PHARMA
5.5.2020 13:03:14 CEST | Business Wire | Press release
Regulatory News:
Vifor Pharma announced that its partner, Akebia Therapeutics, Inc ., today reported positive top-line results from INNO2 VATE, Akebia’s global phase-III cardiovascular outcomes program evaluating the efficacy and safety of vadadustat, an investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), versus darbepoetin alfa for the treatment of anaemia due to Chronic Kidney Disease (CKD) in adult dialysis-dependent patients (DD-CKD). Upon successful completion of its phase-III program, which includes Akebia’s studies of vadadustat for the treatment of anemia due to CKD in non-dialysis patients, Akebia plans to submit a New Drug Application (NDA) for vadadustat for the treatment of anemia due to CKD in dialysis dependent and non-dialysis dependent patients, to the U.S. Food and Drug Administration (FDA).
“We are delighted with the positive top-line data from Akebia’s INNO2 VATE global phase-III global study of vadadustat for the treatment of anemia due to CKD in dialysis patients,” comments Stefan Schulze, Vifor Pharma President of the Executive Committee and Chief Operating Officer, “By successfully meeting its primary efficacy and cardiovascular endpoints, we believe the INNO2 VATE data positions vadadustat as a potential new oral standard of care for treating all populations of dialysis patients, including both incident and prevalent dialysis patients with anemia due to CKD, subject to its approval. We look forward to working with Akebia to bring vadadustat, upon approval, to our dialysis patients.”
Vifor Pharma was granted an exclusive license to sell vadadustat to Fresenius Kidney Care dialysis centers and to specific third party dialysis organisations that together account for approximately 60% of the dialysis patients in the US, subject to approval of vadadustat by the FDA and its inclusion in Medicare’s bundled reimbursement model for dialysis, or reimbursement using the Transitional Drug Add-On Payment Adjustment (TDAPA), and a milestone payment by Vifor Pharma.
About Akebia’s Global phase-III INNO2 VATE Program
Akebia’s public announcement highlighted that its global INNO2 VATE program is a cardiovascular outcomes program which includes two separate phase-III studies (Correction/Conversion and Conversion ) and which collectively enrolled 3,923 dialysis-dependent patients with anemia due to chronic kidney disease (CKD). Both INNO2 VATE studies are global, multicenter, open label (sponsor blinded), active-control (darbepoetin alfa- an injectable erythropoiesis stimulating agent (ESA)), non-inferiority studies. According to Akebia’s announcement: “Vadadustat achieved the primary and key secondary efficacy endpoint in each of the two INNO2 VATE studies, demonstrating non-inferiority to darbepoetin alfa as measured by a mean change in hemoglobin (Hb) between baseline and the primary evaluation period (weeks 24 to 36) and secondary evaluation period (weeks 40 to 52). Vadadustat also achieved the primary safety endpoint of the INNO2 VATE program, defined as non-inferiority of vadadustat versus darbepoetin alfa in time to first occurrence of major adverse cardiovascular events (MACE), which is a composite of all-cause mortality, non-fatal myocardial infarction, or non-fatal stroke across both INNO2 VATE studies. Each analysis was measured against non-inferiority (NI) margins agreed upon with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).”
About Vadadustat
Vadadustat is Akebia’s oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor currently in global Phase 3 development for the treatment of anemia due to CKD. Vadadustat is designed to mimic the physiologic effect of altitude on oxygen availability. At higher altitudes, the body responds to lower oxygen availability with stabilization of hypoxia-inducible factor, which can lead to increased red blood cell production and improved oxygen delivery to tissues. Vadadustat is an investigational therapy and is not approved by the U.S. Food and Drug Administration (FDA) or any regulatory authority.
Please visit https://akebia.com/pr-552020/ to access the complete public announcement from Akebia Therapeutics, which does not form a part of this release.
Vifor Pharma Group is a global specialty pharmaceuticals company. It aims to become the global leader in iron deficiency, nephrology and cardio-renal therapies. The company is the partner of choice for pharmaceuticals and innovative patient-focused solutions. Vifor Pharma Group strives to help patients around the world with severe and chronic diseases lead better, healthier lives. The company develops, manufactures and markets pharmaceutical products for precision patient care. Vifor Pharma Group holds a leading position in all its core business activities and consists of the following companies: Vifor Pharma; Vifor Fresenius Medical Care Renal Pharma (a joint company with Fresenius Medical Care); and OM Pharma. Vifor Pharma Group is headquartered in Switzerland, and listed on the Swiss Stock Exchange (SIX Swiss Exchange, VIFN, ISIN: CH0364749348). For more information, please visit www.viforpharma.com
View source version on businesswire.com: https://www.businesswire.com/news/home/20200505005517/en/
Link:
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Amadeus Explores Next-Generation Flight Search with NVIDIA21.10.2026 14:00:00 CEST | Press release
Amadeus and NVIDIA have been collaborating to explore how accelerated computing and travel-specific AI could support faster, more scalable and more efficient flight search. Building on this work, the companies have now signed a Memorandum of Understanding (MoU) to deepen their collaboration and accelerate further exploration. As AI assistants increasingly search on behalf of travelers, they are changing both the volume and complexity of demand placed on travel technology. Amadeus, in collaboration with NVIDIA, have already conducted initial technical assessments and benchmarking activities, on the NVIDIA Hopper and Blackwell platform, NVIDIA's accelerated computing architectures designed for AI and high-performance computing workloads, to better understand how accelerated computing could support large-scale travel shopping workloads. Through the MoU, Amadeus and NVIDIA will continue this collaboration, with aims to deliver faster, more scalable and more efficient flight search as AI-po
TreviPay Expands Pay by Invoice Availability for Walmart Business Customers21.10.2026 14:00:00 CEST | Press release
The general availability gives eligible organizations more flexibility with net 30-day terms, a dedicated business line of credit and streamlined reconciliation TreviPay, a global B2B payments infrastructure partner, today announced the general availability of Pay By Invoice for eligible Walmart Business customers. Following an initial pilot, the expanded availability gives more organizations a new way to manage purchasing and payments online and in Walmart stores. Walmart Business Pay By Invoice provides net 30-day terms, a dedicated business line of credit and detailed invoicing built into the Walmart Business purchasing experience. Powered by TreviPay, Walmart Business Pay By Invoice is designed to give organizations greater flexibility in how they manage business purchases and payments. Eligible customers can get what they need and pay on net 30-day terms, helping them preserve cash flow for other priorities while keeping operations moving. Purchasing controls and payment reconcili
Global Network for the Advancement of Metabolic Psychiatry (MetPsy) Launches with $20 Million Investment in Clinical Care, Education and Research at McLean Hospital21.10.2026 14:00:00 CEST | Press release
Baszucki Group funding awarded to McLean Hospital to establish a flagship clinical and research center, and jointly to McLean and MH² for medical education and training initiatives Baszucki Group today announced the launch of the Global Network for the Advancement of Metabolic Psychiatry (MetPsy), uniting researchers and clinicians worldwide to advance evidence-based practice in metabolic psychiatry through clinical care, education, and research. The launch is accompanied by a new $20 million grant from Baszucki Group to build a clinical and research center at McLean Hospital, a member of Mass General Brigham, creating the infrastructure to deliver metabolic approaches to psychiatric care at scale. The grant also supports medical education and training initiatives co-led by MH², a clinical practice, training and education hub. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261021217733/en/ MetPsy, a global network for metabo
Starburst Introduces Starburst Torin, a GPU-Native Analytics Engine Built on NVIDIA cuDF21.10.2026 13:30:00 CEST | Press release
Starburst Torin runs SQL natively on NVIDIA GPUs, delivering up to 7x faster query performance to accelerate AI agents and enable data teams to run more workloads without moving data or changing existing SQL or applications. Starburst today announced limited general availability of Starburst Torin, a GPU-native, Trino-based analytics engine for Starburst Enterprise. Built on NVIDIA cuDF, Torin accelerates SQL workloads with native GPU execution, delivering up to 7x faster query performance.1 By complementing Starburst’s existing CPU engine, Torin gives enterprises the flexibility to run workloads on CPUs or GPUs without changing existing Trino SQL queries, applications, or agents. AI agents create a different kind of load on data platforms. A single agent task can trigger a chain of dependent queries, where delays in one query can slow the entire workflow. These bottlenecks also affect interactive analytics, making it harder to explore data, evaluate results, and make decisions in real
Compvide Announces Commercial Launch of CIMED and Presents New Research at European Meeting on Complement in Human Disease (EMCHD) 202621.10.2026 12:47:00 CEST | Press release
Compvide, Inc. today announced the commercial launch of its CIMED platform. The CIMED-AP, CIMED-LP, and CIMED-CP kits assess the alternative, lectin, and classical complement pathways, respectively, using 50% serum to support testing under more physiological conditions. The commercial launch follows Compvide’s participation in the 20th European Meeting on Complement in Human Disease (EMCHD), held September 1–5, 2026, in Cardiff, Wales. Through a scientific presentation, poster, and exhibition, the company shared research highlighting the importance of assay conditions in evaluating complement activity and the effects of complement-targeting therapies. Unlike conventional assays that often use highly diluted serum, CIMED assays use 50% serum. Research presented by Compvide at EMCHD highlighted how serum dilution can influence measurements of complement inhibition, particularly at lower drug concentrations. These findings underscore the importance of assay conditions when evaluating pote
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom