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
Daiichi Sankyo Appoints Markus Kosch to Lead Europe Business as Part of New Commercialization Organization24.8.2026 10:00:00 CEST | Press release
Daiichi Sankyo (TSE: 4568) today announced the appointment of Markus Kosch, MD, as Head of Europe Business, effective April 1, 2027. In this role, he will lead the company's European business within the new globally integrated Commercialization Unit and serve as General Manager of Daiichi Sankyo Europe GmbH, with legal responsibility for the company in Europe. The appointment reflects the next phase of growth of Daiichi Sankyo under its Five-Year Business Plan and the establishment of a new Commercialization Unit. Within this new structure, Markus Kosch will bring together the Oncology and Specialty businesses in Europe under one integrated leadership model to help bring innovative medicines to more patients across the region. For the past five years, Markus Kosch has led the Daiichi Sankyo Oncology Business Division in Europe and Canada, overseeing a period of significant growth and preparing the organization for an increasingly expanding oncology portfolio. Prior to joining Daiichi S
European Commission Approves DAYBU® (trofinetide) as the First and Only Treatment for Neurobehavioral Symptoms of Rett Syndrome in the European Union24.8.2026 09:01:00 CEST | Press release
Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that the European Commission (EC) has granted marketing authorization for DAYBU (trofinetide) for the treatment of neurobehavioral symptoms of Rett syndrome in adults and pediatric patients aged five years and older, making it the first and only treatment approved for Rett syndrome in the European Union (EU). “The approval of DAYBU marks a significant milestone for the Rett syndrome community in the EU and advances our mission to bring this innovative treatment to patients and families who have long faced a profound unmet medical need,” said Catherine Owen Adams, Acadia’s Chief Executive Officer. “For people living with Rett syndrome, a devastating rare neurodevelopmental disorder, there have been no approved treatment options in the EU. We are proud to make DAYBU available and look forward to supporting patients, caregivers, and healthcare providers gain access to treatment." The DAYBU marketing authorization in the EU is prim
ORZEYFUL (oveporexton) Approved in Japan as the First and Only Medicine to Treat the Underlying Cause of Narcolepsy Type 124.8.2026 08:36:00 CEST | Press release
Discovered by Takeda in Japan, ORZEYFUL has the Potential to Redefine Care Beyond Individual Symptom Management for Adults Living with Narcolepsy Type 1 (NT1) Landmark Phase 3 Studies Demonstrated Significant and Meaningful Improvements Across the Full Range of NT1 Symptoms Evaluated in Clinical Trials Compared to Placebo Milestone Marks Third Major Regulatory Approval Secured for ORZEYFUL Around the World Takeda (TOKYO:4502/NYSE:TAK) announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) approved the use of ORZEYFUL (oveporexton) for the treatment of narcolepsy type 1 (NT1, narcolepsy with cataplexy) in adults. ORZEYFUL is a first-in-class oral orexin receptor 2 (OX2R) agonist and the only medicine indicated in Japan to treat the disease holistically rather than individual symptoms. The discovery of this new class of medicine originated in Takeda's laboratories in Japan. Takeda is proceeding with launch preparations and expects to make ORZEYFUL available as quickly
Fasset Hits $1B Valuation as SBI Group Leads $68M Series C to Scale AI-Powered Stablecoin Neobanking24.8.2026 08:03:00 CEST | Press release
Round led by SBI Group follows $51 million Series B raise in May 2026, marking ascent as one of the fastest-growing neobanking platforms. Capital will expand Own Network and deepen AI across stablecoin settlement, tokenization, and corridor banking. Fasset now processes more than $40 billion in annualized transaction volume, serving 3 million+ wallets and more than 1,000 enterprises across 125 countries. Fasset, the AI-powered stablecoin neobanking platform, today announced it has raised $68 million in Series C funding at a $1 billion valuation. The financing was led by SBI Group and follows Fasset’s $51 million Series B earlier this year, which brought Speedinvest onto the cap table alongside a group of strategic investors. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260823503947/en/ Mohammad Raafi Hossain, Co-Founder and CEO, Fasset The new capital will support the expansion of Own Network, Fasset’s regulated financial
Zanders Expands DACH Region with New Office in Vienna, Austria24.8.2026 07:11:00 CEST | Press release
Zanders, the global treasury, risk, and technology consultancy, today announced a significant expansion of its DACH region with the opening of a new office in Vienna. The move builds on Zanders' continued growth across Germany, Austria, and Switzerland, and marks another step in the firm's strategy of deepening its presence in the markets where client demand for specialized treasury, risk, and corporate finance advisory is growing fastest. DACH has been one of Zanders' priority regions for several years, with the firm steadily expanding its team and client base across Germany and Switzerland. Austria represents a natural next step in that growth: in conversations with clients in the market, Zanders has seen growing interest in treasury transformation and financing support, as companies work through interest rate volatility, refinancing needs, and a broader shift toward more digitized, centralized treasury operations. The new Vienna office allows Zanders to be closer to clients' operati
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