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
Angelalign Technology Inc. (6699.HK) Applauds European Court Rejection of Patent Infringement Claim12.5.2026 19:39:00 CEST | Press release
Angelalign Technology Inc. (6699.HK) (“Angel”) (http://www.angelaligner.com) today said it was grateful that the Local Division Düsseldorf (Germany) of the Unified Patent Court rejected a request by Align Technology Inc. (ALGN) for Angel to cease and desist from using its A7 Premolar Extraction Solution. Angel denied that the A7 tooth movement protocol infringes any patents as alleged by Align Technology Inc. (ALGN). The court rejected Align’s request for Angel to preliminarily cease its use of the feature, a decision Angel applauded. “We respect the Düsseldorf Local Division’s ruling and will continue to make our case that Angel has not violated any valid patents,” said Dr. Arno Riße, Angel’s attorney at the Arnold Ruess law firm of Düsseldorf. “We are grateful that the court decided not to grant Align's request for preliminary measures. Angel takes intellectual property rights seriously and is careful not to infringe on legitimate patents.” “We categorically deny the allegations of i
Bharat Forge Signs Long-Term Contract with Embraer for Landing Gear Forgings12.5.2026 18:38:00 CEST | Press release
Bharat Forge Ltd. (BFL) (BSE: 500493, NSE: BHARATFORG), a global leader in advanced forging and precision engineering, today announced a long-term contract with Embraer for the manufacturing and supply of critical landing gear forgings. With this milestone, Bharat Forge becomes the first Indian supplier to join Embraer’s global aerospace supply chain for forged components. Under the agreement, Bharat Forge will supply high-integrity forged components for landing gear systems across Embraer’s commercial and Defence aircraft programs. This engagement establishes a strategic partnership anchored in advanced manufacturing capabilities, precision engineering, and proven expertise in delivering complex, safety-critical components for global aerospace platforms. The long-term contract reflects a shared commitment to quality, reliability, and sustained collaboration, and reinforces Embraer’s confidence in Bharat Forge’s ability to meet stringent global certification standards while consistentl
De' Longhi Group - 6.6% Growth at Constant Exchange Rates and Accelerated Net Profit: Solid Results Fully Support Guidance12.5.2026 18:37:00 CEST | Press release
The Group closed another quarter with robust organic growth, driven by the excellent expansion of the professional division, with turnover growing significantly and representing 18% of the Group's total for the period, and by the positive performance of the household The Board of Directors of De' Longhi S.p.A. approved the consolidated results 1for the first quarter of 2026: In the first quarter the Group achieved: revenues of € 777.7 million, up 3% (+6.6% at constant exchange rates); adjusted 2Ebitda of € 125.9 million, equal to 16.2% of revenues (15.4% in Q1-25); net profit (pertaining to the Group) of € 61.7 million, equal to 7.9% of revenues and up 7.5% compared to the previous year; net financial position at the end of March 2026 of € 720.5 million. CEO Fabio de' Longhi commented: “The start of 2026 was marked by solid revenue growth of 6.6% at constant exchange rates, continuing the excellent performance achieved in recent years. The professional division's strong expansion susta
Multi-Color Corporation Successfully Completes Comprehensive Financial Restructuring12.5.2026 18:09:00 CEST | Press release
Company Emerges Stronger, Well-Positioned to Execute Long-Term Strategy With Significantly Deleveraged Balance Sheet Multi-Color Corporation ("MCC" or the "Company") today announced the successful completion of the Company’s financial restructuring process and emergence from its prepackaged Chapter 11 process. The Company’s prepackaged restructuring reduced net debt by approximately $3.8 billion, reduced annualized cash interest expense by more than $330 million, and extended long-term debt maturities to 2033. More than 99% of voting stakeholders voted to accept MCC’s Plan of Reorganization. Upon emergence, MCC also received a significant $889 million new common and preferred equity investment from CD&R and a group of MCC’s existing secured lenders to support MCC’s long-term growth and investment. "Today marks a significant milestone for MCC, as well as our customers, teammates, and partners who have supported us throughout this process,” said Hassan Rmaile, President and Chief Executi
New Cessna Caravans to Boost USDA’s Fight Against Crop-Damaging Insects12.5.2026 17:00:00 CEST | Press release
Textron Aviation Inc., a Textron Inc. (NYSE: TXT) company, today announced that the U.S. Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) has ordered three Cessna Caravan aircraft to support its sterile insect release program protecting citrus crops along the Rio Grande River in southern Texas. The new aircraft are expected to be delivered in 2027. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260512676348/en/ Mission-Ready: The Cessna Caravan joins USDA’s fight to protect Texas citrus from invasive pests APHIS will use the Caravans to carry and release sterile insects that help prevent the spread of destructive pests, including fruit flies. The environmentally friendly technique helps safeguard fruit-bearing trees, reduce crop damage and protect agricultural industries that rely on healthy harvests. “These aircraft will help APHIS reach remote areas and carry out their important mission o
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