VIFOR-PHARMA
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
Celonis Unveils Platform Innovations to Power the AI-Driven, Composable Enterprise4.11.2025 11:00:00 CET | Press release
Celonis, a global leader in Process Intelligence, today at Celosphere 2025 announced major platform innovations that power enterprise AI to reinvent and continuously improve business operations. Daniel Brown, Chief Product Officer at Celonis, emphasized the need for a structured approach to agentic AI. “To truly operationalize AI, you need to identify the right use cases, redesign your business processes, and orchestrate the agents alongside your people and existing systems," Brown said. "Our enhanced capabilities empower our customers and their partners to build AI solutions that lift their operations to unprecedented levels of efficiency and agility.” The Celonis Process Intelligence Platform extracts raw data from systems, applications and devices within and across enterprises. It enriches this data with customers’ unique business context to create a living digital twin of operations—the Process Intelligence Graph. On top of the Graph, the Process Intelligence Platform provides the
Celonis Partners with Databricks to Power Enterprise AI that Continuously Improves Business Operations4.11.2025 11:00:00 CET | Press release
Direct live access to data gives organizations the process-centric context they need to make AI work in the enterprise Celonis, a global leader in Process Intelligence, today announced a partnership with Databricks, the Data and AI company, to provide customers with a seamless, powerful pathway to operationalize AI. The integration leverages Delta Sharing to directly connect the Celonis Process Intelligence Platform with the Databricks Data Intelligence Platform. Delta Sharing is Databricks’ open source approach that enables customers to share live data across platforms, clouds and regions with strong security and governance. This bi-directional integration, powered by Delta Sharing, eliminates the need to move or copy data between the two platforms. It breaks down data silos, reduces data copies, limits synchronization errors, enhances security, and simplifies data governance. With data and process intelligence flowing freely between the two platforms, customers get a continuous learn
Celonis Customers Drive Tangible Business Outcomes with Enterprise AI powered by Process Intelligence4.11.2025 11:00:00 CET | Press release
At Celosphere 2025, Celonis highlighted that 120 “Value Champions” have realized more than $10 million in value each and $8.1 billion in total. Celonis, a global leader in Process Intelligence, today at Celosphere 2025 showcased how leading companies from around the world are reinventing their operations and generating real business results using Enterprise AI, powered by Process Intelligence (PI). "We see so many organizations struggling to get a return on their AI investments,” said Alex Rinke, Celonis co-CEO and co-founder, during his keynote address. “This often happens because they’re thinking about ‘Enterprise AI’ as a technology. In reality, it’s the strategic discipline of infusing AI into every part of their operations. This is what Celonis and our partners help our customers do. We give their AI the context it needs. We guide them to deploy it in the right places. And, we enable them to make it work with everything else they’re doing.” Customer momentum driven by Celonis’ ope
ExtraHop® Expands Presence in EMEA to Meet Enterprise Demand for NDR4.11.2025 10:00:00 CET | Press release
Extends strategic partnership with Ignition Technology to fight modern cyber threats in Northern European markets ExtraHop®, a leader in modern network detection and response (NDR), today announced its expansion into the Nordics and Benelux markets. This strategic move strengthens the company's European footprint on the heels of a period of significant enterprise growth. Following a strong 2024, in which ExtraHop more than doubled its sales to Global 2000 customers in EMEA, the company is bringing its proven momentum to two of the continent's most dynamic markets housing global enterprise headquarters and a thriving ecosystem of world-class tech innovators. To introduce its industry-leading NDR platform to the Nordics and Benelux regions, ExtraHop is extending its distribution agreement with Ignition Technology, a specialist in SaaS-based cybersecurity. Building upon the partnership’s success in the UK and France, the expansion will address growing demand in northern and western Europe
STV to Deploy Post-Quantum’s Secure Communications Platform, Forms Strategic Cooperation to Deliver Next-Generation Security4.11.2025 10:00:00 CET | Press release
STV Group a.s. (“STV”), one of the world’s fastest-growing defence innovators, has signed a multi-year licence agreement to use Post-Quantum’s groundbreaking quantum-safe communications platform and signed a Strategic Cooperation Agreement to accelerate deployment across Europe, NATO, and global defence markets. With quantum computing threatening to render traditional encryption obsolete, the move positions STV at the forefront of the cybersecurity revolution - arming governments, defence forces, and enterprises with next-generation resilience against “Harvest Now, Decrypt Later” attacks. By fusing Post-Quantum’s NATO-tested modular platform with its own world-class defence solutions, STV is setting a new global benchmark for secure communications and digital trust. Together, the two companies are delivering the most advanced, future-proof systems to protect sensitive data and mission-critical operations - ensuring that even in the quantum era, allied communications remain impenetrable
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