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
ees Europe: Green Hydrogen: Opportunities and Production Ramp Up10.6.2026 16:13:00 CEST | Press release
For the major economies, the transformation towards a climate-neutral industry is one of the central tasks for the coming decades. While the European Union has pledged climate neutrality by 2050, China’s goal is to be climate-neutral by 2060. Hydrogen is a key to transforming their manufacturing and energy industry. However, the actual market development is lagging behind these ambitious objectives: According to the Global Energy Report 2025, only 11 percent of hydrogen projects announced since the start of the decade are now in operation or have been secured by investment decisions. This is why ees Europe, Europe’s largest and most international exhibition for batteries and energy storage systems, is putting a spotlight on hydrogen. The newly aligned exhibition segment Hydrogen Dialogue Forum & Expo in hall B2 will be giving in-depth information about the opportunities for hydrogen technology, technological innovation, savings potential and ground-breaking projects from June 23–25. Th
Info-Tech Research Group Recognizes Laserfiche as a Champion in the 2026 Enterprise Content Management – Enterprise Emotional Footprint Report10.6.2026 16:00:00 CEST | Press release
Laserfiche has been named a Champion for the enterprise category in the Enterprise Content Management Emotional Footprint 2026 Report by Info-Tech Research Group. Laserfiche — the leading SaaS provider of intelligent content management — was recognized based on reviews provided by end users. Laserfiche was recognized as a Champion for delivering significant business value, continued product innovation, and strong customer experience. “We are honored to be named a Champion by Info-Tech Research Group, which we believe underscores our relationships with our customers and commitment to their long-term success,” said Thomas Phelps, CIO and SVP of corporate strategy at Laserfiche. “We are grateful to our customers for partnering with us as we support their needs for AI-driven information management solutions. Of the 285 customers who completed an Info-Tech survey this year, 99% said they plan to renew.” Info-Tech Research Group’s Emotional Footprint report quantifies the end-user experience
BTG Pactual TIG Acquires Jamestown’s Timberland Platform10.6.2026 15:30:00 CEST | Press release
Acquisition includes approximately 90,000-acre U.S. timberland portfolio BTG Pactual Timberland Investment Group (BTG Pactual TIG), one of the world’s largest timberland investment managers, today announced the acquisition of approximately 90,000 acres of U.S. timberland formerly managed by Jamestown, a global design-focused real estate investment and management firm. The Jamestown timberland platform will be integrated into BTG Pactual TIG’s core U.S. timberland strategy’s portfolio. The portfolio of high-quality timberland spans five U.S. states, including approximately 50,000 acres of pine timberland in Georgia and Alabama and approximately 40,000 acres of diversified hardwood timberland across Indiana, Pennsylvania, and New York. All properties are certified under the Sustainable Forestry Initiative (SFI). The acquisition increases BTG Pactual TIG’s core U.S. timberland strategy’s portfolio to more than 1.7 million acres. The firm manages 3.3 million acres globally. The transaction
Solana Becomes Presenting Sponsor of the World Series of Poker®10.6.2026 15:00:00 CEST | Press release
WSOP to Bring Crypto to Global Events Through Solana-Powered Tournament Ticket Purchases The World Series of Poker (WSOP®), the longest-running and most prestigious poker tournament series in the world, today announced a first-of-its-kind collaboration with the Solana Foundation to bring crypto directly into the global poker experience. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260610344534/en/ The World Series of Poker TV production set in Las Vegas, presented by Solana Beginning today at the 57th annual summer event at Paris Las Vegas and Horseshoe Las Vegas, players will be able to purchase tournament tickets using Solana, powered by MoonPay’s payment infrastructure. This will be the first time in WSOP history where players can buy tournament tickets directly with crypto, and by leveraging Solana’s technology, this payment method will have zero processing fees. The integration will expand further at the 2026 WSOP Par
Capcom’s Dragon’s Dogma 2: Dark Arisen Scheduled to Launch on October 9, 2026!10.6.2026 15:00:00 CEST | Press release
– Capcom seeks to further broaden its user base through expansion content and a new platform launch – Capcom Co., Ltd. (TOKYO:9697) today announced that Dragon’s Dogma 2: Dark Arisen, which includes an expansion for Dragon’s Dogma 2, is scheduled to be released on October 9, 2026. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260610422753/en/ Dragon's Dogma 2: Dark Arisen logo The Dragon’s Dogma series consists of action games in a fantasy setting where players adventure in an expansive open world of swords and magic. Since the release of the first game in 2012, the series garnered praise worldwide for gameplay features such as its “pawn” adventure companions who can carry out actions on their own, leading the series to over 14 million* units sold cumulatively. Dragon’s Dogma 2: Dark Arisen is a paid expansion title that adds a new story to Dragon’s Dogma 2, which was released in March 2024. Based on the wide range of feedb
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
