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
Beacon Acquires Haize Labs to Power AI for the Real Economy17.9.2026 16:30:00 CEST | Press release
Haize Labs leadership will anchor Beacon’s new applied AI research group, accelerating the deployment of AI across the essential businesses Beacon owns Beacon Software (Beacon), the first centralized AI holding company, today announced that it has acquired Haize Labs, an AI reliability company that tests and safeguards AI agents for real-world deployment. The Haize Labs team will join Beacon to form its Applied AI Research Group, with co-founder and CEO Leonard Tang joining as VP of AI Research to lead the AI operating system that is deployed across Beacon’s companies. Beacon believes that the fastest way to bring AI to the traditional economy is through the software businesses that essential industries already use and trust, equipping them with AI infrastructure. Beacon acquires these businesses for long-term growth and connects them to a centralized AI operating system that compounds with each additional acquisition and industry. The addition of the Haize Labs team will strengthen th
TIMELAB Develops OEM/ODM Hair Straightener Reaching 200°C at All Three Measured Points in 15 Seconds17.9.2026 16:00:00 CEST | Press release
Testing at 230 V with a 260°C setting confirmed at least 200°C after 15 seconds at all three measured plate locations (front, center and rear), not just a single point. TIMELAB Co., Ltd., a Japanese beauty-appliance OEM/ODM provider, has developed a hair straightener for OEM/ODM customization for international hair care brands and professional markets. In testing at 230 V with a 260°C setting, all three measured plate locations reached at least 200°C after 15 seconds. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260914187865/en/ Three-Point Plate Testing A European-market development unit with a maximum setting of 260°C was tested at 230 V. Fifteen seconds after power-on, readings at the front, center and rear were 212.5°C, 227.5°C and 200.0°C, respectively. From around 60 seconds onward, temperature differences among the three points narrowed, indicating a stable trend. Precision Temperature Control An NTC sensor inside t
Earnix Brings Agentic AI to the Decisions That Drive Insurance Performance17.9.2026 15:09:00 CEST | Press release
Agent Hub, part of Earnix AIOS, brings more than 25, insurance-specific agents and apps into Earnix’s governed pricing, underwriting, and customer decision solutions- improving workflows and business performance Earnix today announced the introduction of Agent Hub, a curated catalog of insurance-specific AI agents and apps within Earnix AIOS — the AI Orchestration System powering Earnix’s pricing and rating, underwriting, and customer engagement solutions. Agent Hub brings agentic AI directly into these solutions, enabling more intelligent workflows and strengthening the high-stakes decisions that shape pricing, underwriting, customer engagement, growth, and profitability. In an increasingly turbulent insurance environment, the useful life of an insurance decision is getting shorter. Risk and market conditions are changing faster, making growth, profitability, and portfolio performance harder to manage. AI is increasing the speed and scope of what insurers can analyze, recommend, and i
Medisca Launches Global Peptide Division17.9.2026 15:07:00 CEST | Press release
New division brings API-grade peptides and Medisca’s quality-first pharmaceutical expertise to a rapidly evolving area of personalized medicine Medisca today announced the launch of Medisca Peptides, a dedicated global division focused on expanding access to API-grade peptides and building an integrated peptide platform for pharmaceutical and personalized medicine markets worldwide. As the peptide landscape evolves, Medisca is proactively building the capabilities and infrastructure needed to support API-grade peptides within applicable regulatory frameworks. The launch represents a significant long-term commitment to peptides, including the expansion of Medisca’s portfolio, strategic manufacturing relationships, and the pharmaceutical infrastructure needed to support the category’s growth. It also signals Medisca’s ambition to become a leading force in the next generation of peptide innovation. For Medisca, the opportunity is familiar. More than 35 years ago, the company was founded t
Elliptic Launches Its Decode Agent to Answer On-Chain Risk Questions and Shows Its Work17.9.2026 15:00:00 CEST | Press release
Hours of tracing, answered in seconds, with the evidence attached Elliptic, the global leader in on-chain risk, today launched Decode, an AI agent built on Elliptic’s intelligence platform. The Decode agent answers natural-language questions about cryptoasset addresses and their exposure in seconds, and returns the evidence behind every answer. Compliance and investigations teams need answers to questions nobody planned for. Getting them out of the data is now a specialist skill, so the questions wait for someone who has it, or go unasked. Meanwhile illicit actors move at machine speed, and agents are starting to sit on both sides of a payment. General-purpose AI assistants can produce an answer. They cannot show where it came from. A fluent response with nothing behind it cannot be put in front of a second-line reviewer, an auditor, or a regulator. “The market is full of AI that asks to be trusted. That is not good enough when someone asks how you reached a decision,” said Jackson Hul
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