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
GenBio AI Builds First World Model of the Human Cell18.8.2026 15:00:00 CEST | Press release
First-of-its-kind system simulates human cell behavior across the full biological hierarchy, from DNA and RNA through protein to the whole-cell level GenBio AI ('GenBio') is an AI for Science company co-founded by Nobel Laureate David Baker, leading AI scientist Eric Xing, and other prominent life science and artificial intelligence researchers from Stanford, Carnegie Mellon University, Mohamed Bin Zayed University of Artificial Intelligence, Harvard, Weizmann Institute, and other research institutions. Today, the company introduced AIDO Cell, its virtual cell world model — the first system capable of simulating a human cell, both in its natural state and in response to drugs and other interventions, across its full biological hierarchy, from DNA and RNA through protein to the whole-cell level. A Key First in Biological and Medical Sciences: Full-hierarchy virtual cell simulation has been widely identified as a key milestone in computational biology. Compared to the previous efforts by
Xsolla Partner Network Expands Verified Creator Partnerships and Unifies Campaign Management Ahead of gamescom 202618.8.2026 15:00:00 CEST | Press release
Developers Gain Vetted Creator Partnerships And A Single Campaign Workflow, Managed From The Publisher Account They Already Use Xsolla, a global video game commerce company, today announced an expansion of the Xsolla Partner Network ahead of gamescom 2026 in Cologne, giving game developers a simpler, more reliable way to grow their games through creators. The creator platform now lives within Xsolla Publisher Account, where developers already run their business, with verified creator onboarding and a redesigned and unified campaign workflow. Flat-fee campaigns, a new guaranteed payment option alongside revenue share, and data-driven creator recommendations are coming soon. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260818140062/en/ Graphic: Xsolla Xsolla Partner Network gives developers one place to launch, manage, track, and report on creator campaigns while Xsolla handles payments, payouts, taxes, and compliance.Verifi
KOCCA to Showcase 13 Korean Game Companies at ‘Gamescom 2026’ with PC, Mobile, and VR Lineups18.8.2026 14:48:00 CEST | Press release
- Featuring a diverse lineup of roguelike deckbuilders, AI-powered rhythm education, and cooperative horror games - Ranging from new titles based on the popular animated IP ‘LARVA’ to real-time K-POP dance coaching content - Hands-on experience available August 26–28 at the Korea Joint Pavilion B2B Hall, Koelnmesse, Booth Hall 3.2 C-050g–D051g The Korea Creative Content Agency (KOCCA) announced that 13 Korean game companies will gather under one roof at Gamescom 2026, Europe’s largest game show, held in Cologne, Germany, from August 26 to 28 (B2B, 09:00~20:00). Located in Booth Hall 3.2 C-050g–D051g, the Korea Joint Pavilion offers visitors hands-on experiences with an expansive lineup of titles, ranging from PC and mobile games to VR-powered titles across diverse genres. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260818271881/en/ KOCCA will bring 13 Korean game companies to Gamescom 2026 in Cologne, Germany (Image: KOCC
SLB to Support Offshore Production Restoration for Brunei Shell Petroleum18.8.2026 14:06:00 CEST | Press release
Integrated execution model combines multiple disciplines to improve recovery from mature offshore assets Global energy technology company SLB (NYSE: SLB) today announced it has been awarded a contract by Brunei Shell Petroleum (BSP) to support production restoration from shut-in wells across multiple offshore fields. The contract scope spans subsurface evaluation, well candidate selection, engineering and offshore execution. Project management, intervention services, monitoring, metering and marine logistics are integrated within a single coordinated execution model designed to support efficient production restoration. “Building on our long collaboration in the region, this contract reflects a shared commitment to maximizing value from existing offshore resources,” said Gokhan Yarim, senior vice president of Integration, SLB. “Together with BSP, we are combining SLB’s production expertise and integrated execution capabilities to help restore production from shut-in wells, increase reco
BeOne Medicines, BeOne Care Foundation, and The Max Foundation Renew Partnership to Expand Access to BRUKINSA® for the Treatment of Chronic Lymphocytic Leukemia in Low- and Middle-Income Countries18.8.2026 12:00:00 CEST | Press release
Renewed collaboration builds on access provided to more than 300 patients with CLL to date and plans to support approximately 1,000 patients through 2028 BeOne Medicines Ltd. (“BeOne”) (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, together with the BeOne Care Foundation, a nonprofit charitable foundation, and The Max Foundation, a leading global health nonprofit organization, today announced the renewal of their partnership through 2028 to expand access to BRUKINSA® (zanubrutinib) for the treatment of chronic lymphocytic leukemia (CLL) in low- and middle-income countries, with the program projected to support approximately 1,000 patients cumulatively. Building on a collaboration launched in 2023, the renewed partnership reflects the organizations’ shared commitment to improving access to innovative cancer treatments in underserved communities. To date, the partnership has enabled access to BRUKINSA for more than 300 patients with CLL across Armenia, Ethiopia, and
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