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
Dompé Doses First Patient in Phase 3 Study of Cenegermin-bkbj in NAION14.7.2026 14:00:00 CEST | Press release
Non-arteritic anterior ischemic optic neuropathy (NAION) is a loss of blood flow to the optic nerve which causes spontaneous and rapid vision loss, for which there are currently no FDA-approved treatments. Given the substantial unmet need for effective treatments in NAION, in October 2025, Dompé was awarded a Commissioner’s National Priority Review Voucher (CNPV) by the US FDA to accelerate a potential Biologics License Application for intranasal nerve growth factor (NGF) in NAION. Dompé, a biopharmaceutical company with operations in Italy and the US, announced the first patient has been enrolled in a Phase 3 study of cenegermin-bkbj for the treatment of non-arteritic anterior ischemic neuropathy (NAION). Involving more than 130 centers globally, the Phase 3 trial, “Galassia-NAION-301” is a multicenter, double-blind study comparing cenegermin-bkbj against placebo in improving vision loss caused by NAION. “Our NGF R&D program continues to accelerate with our third clinical study of 202
CE-IVDR Mark for Hologic’s Aptima® HPV Test Expanded to Include Self-Collected Sample Claim in Cervical Cancer Screening14.7.2026 14:00:00 CEST | Press release
New indication in the European Union and the UK offers alternative method of screening especially for women who are not currently participating Hologic, Inc. announced today that its Aptima® HPV Assay received an expanded CE-IVDR marking in the European Union and the UK and is now approved for self-collected vaginal samples using the Aptima Multitest Specimen Collection Kit. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260714358586/en/ Hologic’s Aptima® HPV Assay and Aptima Multitest Specimen Collection Kit Cervical cancer is the fourth most common cancer in women but is largely preventable through HPV vaccination and regular screening.1 Evidence shows that organized screening and early detection reduces deaths from cervical cancer, with mortality reduction rates in Europe ranging from 41% to 92%.2 However, even in countries with an established cervical screening program, screening participation rates vary widely, from 25%
Cover Genius Raises USD $100M Backed by Vista Credit Partners, Reaching USD $1.9 Billion Valuation as it Advances AI-First Platform and Global Expansion14.7.2026 14:00:00 CEST | Press release
Accelerating the AI roadmap and next era of embedded protection Cover Genius, the global infrastructure for embedded protection, today announced a USD $100M capital raise, backed by Vista Credit Partners, a subsidiary of Vista Equity Partners and strategic financing partner focused on enterprise software. The raise values the business at USD $1.9 billion, advancing a new chapter for the company. Cover Genius operates a B2B2C embedded protection platform that connects 200+ partners with 50+ global insurance carriers to protect over 70 million end customers at the point of sale across travel, retail, ticketing and logistics. Unlike traditional insurers, Cover Genius dynamically adapts product design, pricing, and presentation in real time to match each merchant's unique customer journey and geography mix. “We’ve spent more than a decade building the trust layer the world’s largest digital companies rely on to protect their customers. Today’s raise is about broadening possibilities: movin
Esri to Debut the Power of Where Collection at 2026 Esri User Conference14.7.2026 14:00:00 CEST | Press release
New Titles Expand on Landmark Work to Showcase How GIS Drives Better Decisions Across Water and Land Management Esri will debut the Power of Where Collection at the 2026 Esri User Conference. The collection builds on the 2024 book The Power of Where by Jack Dangermond, extending its ideas into real-world GIS applications. New titles in the collection highlight GIS uses in water forecasting, land records, infrastructure planning, and economic development. The series demonstrates how spatial analysis helps organizations address challenges including sustainability, climate resilience, and governance. Esri, the global leader in location intelligence, will debut the Power of Where Collection at the 2026 Esri User Conference in July. The collection builds on the ideas introduced in The Power of Where: A Geographic Approach to the World's Greatest Challenges, by Esri president Jack Dangermond, published in 2024. The new collection expands these foundational concepts into focused, real-world a
Esri Introduces ArcGIS for ServiceNow, Bringing Location Intelligence into Everyday Enterprise Workflows14.7.2026 14:00:00 CEST | Press release
New Integration Connects Platforms, Enabling Real-Time Mapping Directly Within Existing Systems Esri is launching ArcGIS for ServiceNow, an integration that connects ServiceNow, the AI control tower for business reinvention, with ArcGIS, bringing location intelligence into everyday enterprise workflows. The solution supports organizations across commercial, government, health care, utilities, energy, telecom, and other sectors. Users can visualize incidents, assets, work orders, facilities, and other business data on maps in real time within ServiceNow or ArcGIS, improving decision-making and operational efficiency. The integration eliminates data duplication by enabling seamless data sharing between systems, bridging business records with geographic context. ArcGIS for ServiceNow will debut in beta shortly after Esri User Conference. Esri, the global leader in geographic information system (GIS) technology, has announced ArcGIS for ServiceNow, connecting the two platforms for the firs
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