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
OKX Card Usage Surges Across Europe as Crypto Moves Into Everyday Spending19.8.2026 09:30:00 CEST | Press release
OKX Card purchase volume rises 280% year over year as European customers increasingly use digital assets for groceries, transport and other everyday expenses OKX, a leading global fintech company and crypto trading platform, today announced significant growth in everyday use of the OKX Card across Europe, with purchase volume increasing 280% year over year this summer and transactions rising 178%, as customers increasingly use the Card for routine spending including groceries, transport and fuel. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260819423550/en/ The OKX Card is designed to bridge the gap between holding digital assets and using them in everyday life, bringing earning, spending, and rewards together within the broader OKX ecosystem. The growth comes as crypto cards gain momentum across the wider payments industry. Industry-wide crypto card purchase volume reached a record $759 million in July, signalling that di
SAP strengthens its cloud infrastructure in Germany with BSI-approved Layer 1 encryption from Adva Network Security19.8.2026 09:00:00 CEST | Press release
News summary: SAP needed to secure connectivity between its German data centers to meet strict confidentiality, compliance and data control requirements BSI-approved Layer 1 encryption from Adva Network Security enables SAP to protect all data streams and future-proof its infrastructure against quantum threats Solution strengthens sovereign cloud foundations for government, critical infrastructure and regulated industries with high security and compliance needs Adva Network Security, an Adtran company, today announced that SAP is harnessing its Layer 1 encryption technology to secure connectivity between its data centers in Walldorf and St. Leon-Rot, Germany. The solution secures data directly at the optical transmission layer and is approved by the Federal Office for Information Security (BSI) for information classified up to “Verschlusssache – Nur für den Dienstgebrauch” (VS-NfD) – “For Official Use Only.” By strengthening the protection of data in transit, SAP is enhancing the secur
Qatar to Showcase Its Gaming Ambitions at Gamescom 202619.8.2026 09:00:00 CEST | Press release
Invest Qatar, the country’s Investment Promotion Agency, and Media City Qatar will participate at Gamescom 2026 through the “Qatar Pavilion”, highlighting Qatar’s growing role as a regional hub for game development, digital content and esports. Held annually in Cologne, Germany, Gamescom, a leading global event, brings together developers, publishers, investors and creators. Qatar’s participation reflects its focus on building a competitive, innovation-led ecosystem for gaming and interactive media. Mohammed Al Mulla, Head of Investment Development, Invest Qatar, said: “Gamescom provides a key platform to connect with global gaming leaders and highlight emerging opportunities across Qatar and the wider Middle East. We are focused on enabling companies to enter and scale in a high-growth market through a business environment designed for innovation and long-term success.” Dr. Fahad Abdulla Al Hajri, Business Development Manager, Media City Qatar, said: "Gaming is becoming one of the def
IFF to Webcast Fireside Chat at Barclays Global Consumer Conference on Sept. 1018.8.2026 22:15:00 CEST | Press release
IFF (NYSE: IFF) today announced that Chief Executive Officer Erik Fyrwald will participate in a fireside chat at the Barclays Global Consumer Conference on Thursday, Sept. 10, 2026 at 945 a.m. ET. Investors may access the live webcast on the Company's website at ir.iff.com. For those unable to listen to the live webcast, a recorded version will be made available for replay. Welcome to IFF At IFF (NYSE: IFF), we make joy through science, creativity and heart. As the global leader in flavors, fragrances, and health and biosciences, we deliver groundbreaking, sustainable innovations that elevate everyday products—advancing wellness, delighting the senses and enhancing the human experience.Learn more at iff.com, LinkedIn, Instagram and Facebook. View source version on businesswire.com: https://www.businesswire.com/news/home/20260818490253/en/
Lehman Brothers Treasury Announces the Successful Sale of its Remaining Intercompany Claim against Lehman Brothers Holdings Inc.18.8.2026 21:15:00 CEST | Press release
In connection with its previously announced final wind-down, Lehman Brothers Treasury Co. B.V. in liquidation (“LBT”), through its U.S. counsel Herbert Smith Freehills Kramer (US) LLP, announced that its placement agent, Seaport Loan Products LLC, successfully closed the sale of LBT’s remaining $19.6 billion Class 4A intercompany claim against Lehman Brothers Holdings Inc. The net proceeds of the sale, together with certain available cash (but after deducting various sale-related and other administrative costs and expenses), will be used to fund a final distribution to the holders of LBT’s existing notes, after which such existing notes will be canceled and LBT shall be fully wound down. As a result, LBT will cease to exist. LBT expects the final distribution to occur in the course of October 2026 and the wind down to have been completed before the end of 2026. View source version on businesswire.com: https://www.businesswire.com/news/home/20260818004215/en/
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