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
Invivoscribe Begins Commercial Shipments of PrepQuant™ Systems, Enabling High-Sensitivity Sample Preparation for MRD Testing2.9.2026 21:31:00 CEST | Press release
New automated platform is designed to improve the quality, efficiency, and consistency of DNA extraction and concentration from large-volume blood and plasma samples, supporting downstream assays capable of detecting disease-associated signals at MRD sensitivity levels. Invivoscribe®, a global leader in precision diagnostics and measurable residual disease (MRD) testing, today announced that commercial shipments of the PrepQuant™ System have begun in North America. First unveiled at the American Association for Cancer Research Annual Meeting in April 2026, PrepQuant is now being delivered to customers, marking the platform's progression from development and validation into commercial deployment. The commercial milestone extends Invivoscribe's capabilities into laboratory instrumentation and addresses a critical bottleneck in highly sensitive molecular testing: efficiently recovering, concentrating, and quantifying DNA from larger blood and plasma inputs. PrepQuant is assay agnostic, de
C.H. Guenther Opens Centre of Excellence in Coventry, UK to Accelerate Bakery Innovation and Support Future Manufacturing Growth Across UK and Europe2.9.2026 18:00:00 CEST | Press release
C.H. Guenther & Son LLC (“C.H. Guenther” or “CHG”), a leading food manufacturer, has opened a new Centre of Excellence (the “Centre”) at its flagship Coventry bakery, creating a dedicated innovation and customer collaboration hub designed to accelerate the development of premium bakery products across the UK and Europe. The new facility has been designed to support CHG’s customers including leading global quick service restaurants, foodservice operators and retailers as they develop, test and refine new bakery products. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260902696890/en/ The purpose-built, 172-square-metre Centre of Excellence brings together a commercial-scale bakery, customer demonstration kitchen, sensory evaluation facilities, innovation suite and dedicated collaboration spaces in one specialized location. Designed to support and accelerate product development from concept through to commercial manufacturing,
Record Asset Management Enters New Phase of Growth2.9.2026 17:35:00 CEST | Press release
Record Asset Management GmbH (“RAM”), a subsidiary of London-listed Record plc (“Record” or the “Group”), is pleased to announce that it is now operating cashflow positive, thereby marking a transition from its investment phase into a growth business within the Group, and a significant milestone towards sustainable profitability. RAM is the European asset management arm of Record, the London-listed specialist investment group managing USD 122 billion of assets on behalf of institutional clients worldwide. Record's client base comprises pension funds, foundations, sovereign institutions and other asset managers, with whom the Group has built long-standing relationships through its focus on bespoke investment and risk management solutions. RAM was established as a sister company to Record’s core currency business and obtained its BaFin license in 2022. RAM has grown rapidly in the last two years and has developed into a diversified private markets platform with dedicated infrastructure e
Doha Debates Holds Toronto Town Hall on Football, Money and Fandom2.9.2026 17:10:00 CEST | Press release
A sports journalist, a historian and a filmmaker join students from Qatar, Canada and Mexico to debate the impact of wealthy club backing on football and its fans Football fans embody club loyalty that no boardroom can manufacture. But as global capital reshapes the world’s most-watched sport, who it belongs to is increasingly contested. This question is at the heart of Qatar Foundation’s latest Doha Debates town hall, “Football fandom: Community or commodity?”, now available on Doha Debates and Al Jazeera Digital platforms. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260902833406/en/ Doha Debates Town Hall “Football fandom: Community or commodity?” stage at the Terminal Theatre in Toronto, Canada. (Photo: AETOSWire) The episode was filmed at The Terminal Theatre in Toronto in partnership with the Qatar, Canada and Mexico 2026 Year of Culture, a national initiative that builds lasting relationships between countries by cr
Honoring the World’s Most Exceptional Tourism Destinations: Nominations Now Open for the Second TOURISE Awards2.9.2026 15:55:00 CEST | Press release
The TOURISE Awards showcase the globe's most influential destinations, highlighting the richness of culture, the power of human connection, and groundbreaking advancements in travel. Six categories are open for nominations, including a new award for Best Wellness Destination, plus a flagship Best Overall Destination award selected by the jury. Winners will be honored at the TOURISE Awards ceremony, held in conjunction with the TOURISE Summit in Riyadh, March 23-25, 2027. The second cycle of the TOURISE Awards officially launched today as a continuing global benchmark celebrating premier tourism destinations. The TOURISE Awards set a new global benchmark in 2025, celebrating destinations that deliver distinctive, purpose-driven travel experiences. In 2027, TOURISE will celebrate the destinations shaping tomorrow’s tourism; that deliver value across the entire journey, align with traveler purpose, and set new global standards for how the world travels, connects, and grows. Nominations ar
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