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
AB InBev Reports First Quarter 2026 Results5.5.2026 07:02:00 CEST | Press release
Solid top- and bottom-line performance: Revenue up by 5.8%, Beer volume growth of 1.2% and a 20.8% Underlying EPS increase Anheuser-Busch InBev (Brussel:ABI) (BMV:ANB) (JSE:ANH) (NYSE:BUD): This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260504526109/en/ Regulated information1 “Cheers to beer - the strength of the category and the consistent execution of our consumer-centric strategy drove continued momentum across our footprint. We are investing behind our megabrands and innovations to lead and grow the category. With strong execution by our teams and major moments of celebration ahead, we are well positioned for 2026.” – Michel Doukeris, CEO, AB InBev Revenue +5.8% Revenue increased by 5.8% with revenue per hl growth of 4.5%. Reported revenue increased by 12.0% to 15 267 million USD, positively impacted by currency translation. 8.2% increase in combined revenues of megabrands, led by Corona, which grew by 16% outside of its
Kubota Vision Inc. Signs Supply and Licensing Agreement with Laboratoires KÔL for Stargardt Disease Treatment Candidate Under Compassionate Use4.5.2026 17:16:00 CEST | Press release
Kubota Vision Inc. (“Kubota Vision”), a wholly-owned subsidiary of Kubota Pharmaceutical Holdings Co., Ltd. (Minato-ku, Tokyo, Japan) announced signing of a Supply and Licensing Agreement with Laboratoires KÔL (Clermont-Ferrand, France) for the provision of a Stargardt disease (STGD1) treatment candidate under compassionate use authorization. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260414590785/en/ The purpose of this Agreement is for Kubota Vision and KÔL to collaborate on providing “Emixustat” for treatment of Stargardt Disease (STGD1) through compassionate use authorization in France. Kubota Vision will exclusively manufacture and supply Emixustat final products to KÔL and KÔL will have exclusive rights to distribute Emixustat in France under compassionate use access. Ryo Kubota, Chairman, President, and CEO of Kubota Pharmaceutical Holdings, stated, “We are extremely pleased to enter into this Agreement with Labor
Incentive Market Set to Surpass $80B by 2030s — IMA Launches Tools to Help the Industry Keep Pace4.5.2026 16:28:00 CEST | Press release
With combined business spend on loyalty, employee recognition, and channel incentives projected to exceed $80 billion by the 2030s, the incentive industry is entering a period of rapid scale and strategic pressure. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260422729016/en/ In response, the Incentive Marketing Association (IMA) launched a new suite of resources designed to help incentive professionals navigate an environment that’s becoming more specialized, fragmented, and central to business performance. “It’s not just more money coming in—it’s more complexity,” said Vince Chiofolo, President of the Incentive & Engagement Solution Providers (IESP). “Buyers are demanding programs that evolve fast, integrate deeply, and feel personal at scale. These new tools were built for that.” IMA’s Suite of Tools Includes: New Industry Report — Inside the Incentive Buyer’s Mind Drawn from insights of 50+ program owners, the report f
Tigo Energy Breaks Global Growth Benchmark; Boosts U.S. Energy Feature in Predict+4.5.2026 15:00:00 CEST | Press release
Advanced energy prediction platform adds real-time energy pricing for North American Independent System Operator (ISO) customers, accelerates meters-connected growth. Tigo Energy, Inc. (NASDAQ: TYGO) (“Tigo” or “Company”), a leading provider of intelligent solar and energy solutions, today announced that the Predict+ platform now offers integrated real-time spot market pricing for ISO customers in the United States. Predict+ provides utilities with deep insights into grid demand, renewable generation, and energy market dynamics, enhancing the precision, scalability, and robustness of energy forecasting to up to 97.5% accuracy through machine learning and artificial intelligence. For energy providers, Predict+ helps streamline operations, reduce volatility, and maximize performance. Predict+ empowers utility operators to adapt to real-world demand challenges when balancing renewable and baseload generation sources, particularly during extreme weather events and market disruptions. On th
Airship Announces 2026 Elevate Customer Experience Award Winners4.5.2026 15:00:00 CEST | Press release
Southwest Airlines, The Economist, and OneFootball among brands recognized at Elevate’26 Customer Experience Summit for setting the standard in mobile-first and AI-centered customer experiences Airship, the mobile-first customer experience company, today announced the winners of the 2026 Elevate Customer Experience Awards. Global brand leaders from The Economist, Southwest Airlines, and OneFootball were among those honored at the Elevate’26 Customer Experience Summit. The Elevate Awards spotlight global companies that have developed exceptional mobile-first customer experiences for their customers, created innovative campaigns, leveraged AI agents to reach new levels of productivity, and achieved real business results. "Evolving mobile-first consumer behaviors and unprecedented advancements in AI are driving a seismic shift that is reshaping how brands interact with their customers," said Brett Caine, CEO, Airship. "The 2026 Elevate Award winners aren’t just adapting, they’re leading t
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