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
IntouchCX Recognized for Operations led AI and End to End CX Transformation by HFS Research6.11.2026 15:00:00 CET | Press release
IntouchCX a global leader in AI-powered customer experience (CX) management, trust and safety, digital engagement, and back-office operations, has been positioned in the Horizon 2 end-to-end experience transformation, in the HFS Horizons Customer Experience Services 2026 report for its operations led approach to AI adoption and its model connecting advisory with delivery, from strategy through frontline executions. HFS Research evaluates customer experience service providers based on their capabilities, innovation, and potential to deliver value. The 2026 report examines how providers are helping businesses adopt AI, improve customer experiences and strengthen operations. “AI transformation delivers the greatest value when strategy, technology, and operations work together,” said Brent Stevenson, Chief Experience Officer at IntouchCX. “Our approach and expertise goes beyond technology. We identify business challenges and build the right solutions by connecting the dots between data, wo
The Estée Lauder Companies Unveils Mastering Skin Longevity, a Breakthrough Scientific Innovation Platform Advancing the Next Era of Skin Science6.11.2026 15:00:00 CET | Press release
New Platform Focuses on Master Regulators of Skin Longevity to Drive Discovery Across Ingredients, Technologies, Formulations and Future Product Innovation At the China International Import Expo (CIIE), The Estée Lauder Companies Inc. (NYSE: EL) today unveiled Mastering Skin Longevity, a breakthrough scientific innovation platform designed to advance the next era of skin science and transformative product innovation. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261106776704/en/ The Estée Lauder Companies' Skin Longevity Clock serves as the visual representation for the Mastering Skin Longevity scientific innovation platform. Moving beyond the study of individual Hallmarks of Aging, the platform focuses further upstream on the Master Regulators of Skin Longevity. These interconnected biological pathways and proteins influence multiple hallmarks at once. By deepening understanding of these systems and how they help support s
Experian Named a Leader in 2026 IDC MarketScape for Worldwide Decision Intelligence Platforms6.11.2026 15:00:00 CET | Press release
IDC MarketScape recognizes Experian for strengths in proprietary data foundation, integrated orchestration and deployment flexibilityKey SummaryExperian named a Leader: IDC MarketScape positions Experian as a Leader in its 2026 vendor assessment of worldwide decision intelligence platform providers. Data and decisioning at scale: Experian Ascend Platform™ brings together proprietary data, analytics, decisioning, fraud detection, identity verification and model management and is used to process millions of transactions daily. Agentic AI orchestration and governance: Experian Agent Operating System™ provides a trusted agentic AI layer within Experian Ascend Platform designed to help organizations scale AI with explainability, auditability and human oversight. Experian today announced it has been named a Leader in the IDC MarketScape: Worldwide Decision Intelligence Platforms 2026 Vendor Assessment (Doc #US54118426, September 2026), which evaluates providers helping organizations design,
Midas Atlantic Partners, in Partnership With the Najafi Companies, Has Entered Into a Put Option Agreement With Sylvamo Relating to the Potential Acquisition of Its European Operations6.11.2026 12:04:00 CET | Press release
Sylvamo’s European operations include its uncoated freesheet paper mills in Saillat (France) and Nymölla (Sweden), as well as its forestry and supporting business operations across EuropeRevenues of approximately EUR 630 million for the fiscal year ended December 2025Transaction expected to close in the first quarter of 2027 once the required consultation processes are completed and regulatory approvals are obtained Midas Atlantic Partners (“Midas Atlantic”), in partnership with The Najafi Companies, has signed a put option agreement with Sylvamo Corporation (“Sylvamo”) relating to the potential acquisition of its European operations (the “Business”). The transaction comprises Sylvamo’s uncoated freesheet paper mills in Saillat and Nymölla, as well as its forestry and supporting business operations across Europe. Closing is expected in the first quarter of 2027, once the required consultation processes are completed and regulatory approvals are obtained. The Business is a leading Europ
Suzano Reports 36% Increase in Third Quarter Net Revenue Following Consolidation of Arbex6.11.2026 00:23:00 CET | Press release
Suzano (B3: SUZB3 / NYSE: SUZ) , the world’s largest pulp producer, announces its results for the third quarter of 2026 (3Q26), which for the first time include Arbex, the joint venture between Suzano and Kimberly-Clark established in July this year. Driven primarily by the consolidation of Arbex’s contribution, Suzano reported net revenue of BRL16.5 billion, an increase of 36% on the same period last year and a new quarterly record in the company’s 102-year history. Adjusted EBITDA totaled R$5.7 billion in 3Q26, up 9% on the same basis of comparison. Operating cash generation reached R$3.8 billion, an increase of 12%. Net income totaled R$2.1 billion. As announced following the completion of the transaction with Kimberly-Clark, Suzano holds a 51% equity interest in Arbex and will therefore fully consolidate the joint venture’s financial statements from this quarter onwards.1 “This quarter marks the beginning of a new phase for Suzano. With Arbex, we are now a broader business, both ge
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