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
GasEntec Announces New Ownership Structure, Accelerating Next Phase of Global Growth10.9.2026 11:00:00 CEST | Press release
Independent LNG infrastructure and technology company expands investment in proprietary technology, modular solutions and global project development. GasEntec Holdings Inc., a global LNG technology and assets company, today announced a new ownership structure designed to accelerate GasEntec’s next phase of growth and expand the commercialization of its proprietary LNG technologies and solutions. A consortium led by the Groupe Mimran has acquired a majority stake in GasEntec Holdings Inc., the US holding company, supporting GasEntec’s global growth. Under the new structure, GasEntec Holdings is the parent company of GasEntec’s South Korean operating business. Prior shareholders have exited in full. GasEntec’s customer relationships, contracts, engineering organization and ongoing global operations remain unchanged. GasEntec will continue to operate independently, with its technology development, engineering and operations centered in South Korea and an expanding commercial presence acro
EUMETSAT Takes Control of MTG-I210.9.2026 09:30:00 CEST | Press release
EUMETSAT’s Mission Control Centre in Darmstadt, Germany, took over control of the newest addition to its fleet of meteorological satellites, Meteosat Third Generation Imager 2 (MTG-I2), on 9 September 2026, following the successful completion of its Launch and Early Orbit Phase (LEOP). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260909889951/en/ MTG-I2 in orbit MTG-I2 launched from Europe’s Spaceport in French Guiana on 27 August 2026 and has now reached its geostationary orbit, around 36,000 km above Earth. During LEOP, carried out for EUMETSAT by Telespazio, communications with the satellite were established, its solar arrays deployed and a series of precise manoeuvres brought it to its designated orbital position. The spacecraft has now been handed over to EUMETSAT’s flight operations teams. EUMETSAT, working with ESA and European industry, will now begin extensive calibration and validation activities to prepare the s
LUMI AI Factory Selects IQM's Staged Path to Europe's First Superconducting Quantum Computer With Logical Qubits10.9.2026 09:08:00 CEST | Press release
The upgrade path contains three stages from IQM´s Halocene product line to enable a logical qubit system. The quantum computer, as part of the LUMI AI Factory initiative, is jointly owned by the participating countries of Finland, Czechia, Norway and Poland, and jointly funded by the EuroHPC Joint Undertaking. The system will be installed at CSC – IT Center for Science in Finland and integrated into the LUMI-AI computing environment to form a hybrid HPC, AI, and quantum computing platform. The deployments are in line with IQM’s development roadmap for fault-tolerant quantum computing by 2030. IQM Quantum Computers (Nasdaq: IQMX) today announced its upgrade path for a logical-qubit-capable quantum computer. The deployment to the LUMI AI Factory, led by CSC – IT Center for Science, will support R&D efforts toward fault-tolerant quantum computing and advancements in hybrid computing. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home
Cyviz and SWISS Create Flexible Collaboration Hub for Hybrid Work at Scale10.9.2026 09:00:00 CEST | Press release
Watch Video Case Cyviz AS has delivered a flexible collaboration hub for Swiss International Air Lines Ltd. (SWISS), designed to support hybrid meetings, workshops, training, town halls, and internal events at scale. The project highlights how global enterprises are investing in reliable, intuitive, and versatile collaboration environments as hybrid work becomes embedded in day-to-day operations. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260910985990/en/ Inside the SWISS collaboration hub at their headquarters in Zurich Located at SWISS headquarters in Zurich-Kloten, Switzerland, the new collaboration hub demonstrates how enterprise collaboration spaces are evolving from traditional meeting rooms into strategic workplace infrastructure. Delivered by Cyviz, the environment supports a wide range of hybrid formats while making advanced room technology simple for everyday users. Designed to switch seamlessly between separat
Nothing Cleans Like Oral‑BiO: The Electric Toothbrush That Cleans Deeper, Smarter and Better10.9.2026 09:00:00 CEST | Press release
Oral-B iO delivers a clinically proven deeper, smarter and better clean, with 100% more plaque removal and 6x more plaque removal along the gum line, both compared to a manual toothbrush. Oral‑B, the #1 brand most used by dentists worldwide, today spotlights its most advanced brushing technology: the Oral‑B iO range. Powered by a unique 2-in-1 cleaning technology, iO is engineered to clean deeper into every gap, brush smarter with real-time pressure guidance, and deliver results that are clinically proven to be better. The proof is everything — and nothing cleans like Oral‑B iO. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260904320713/en/ Oral-B iO10 Most people know that an electric toothbrush outperforms a manual one — but not everyone knows why, or what makes one electric brush stand apart from another. Oral‑B iO makes the difference clear: deeper, smarter, better — everywhere. Cleans Deeper: The Technology Behind the
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