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
Arboris Capital Selects ROYC to Expand Private Markets Capabilities on CapGain Platform18.5.2026 09:00:00 CEST | Press release
Arboris Capital Limited (“Arboris”), a DIFC-based firm arranging alternative investments, authorised by the Dubai Financial Services Authority (DFSA), today announced that it has selected ROYC AB (“ROYC”), a private markets technology and infrastructure provider, to support the continued development of its private markets offering through its platform, CapGain. In its ongoing efforts to expand its private markets capabilities across the Middle East, Arboris has undertaken a strategic review of how to further scale its offering while maintaining the integrity of its existing platform. As a result, Arboris has chosen to integrate ROYC’s fund access, sourcing, and structuring capabilities into CapGain, complementing its existing infrastructure. CapGain is Arboris’s proprietary investment platform, purpose-built to facilitate access between international private market opportunities and Professional Investors in the region. CapGain provides fully digital investor onboarding and KYC, a secu
OdysseyRe Announces New Co-Chief Underwriting Officers for EMEA18.5.2026 09:00:00 CEST | Press release
Odyssey Reinsurance Company (OdysseyRe) today announced the appointments of Tegwen Gromellon and Anne-Claire Serres as co-chief underwriting officers of its EMEA division, effective July 1. They succeed longtime Chief Underwriting Officer, Gaël Le Païh, who is retiring later this year following 36 years with the Company. Based in Paris, Serres joined OdysseyRe in 2018 as the market director for France and will lead the division’s business across France, Africa and the Middle East. Gromellon, who joined OdysseyRe in 2004, has served as market director for Germany, Austria, Benelux and Switzerland since 2019. He will take the lead for the rest of Europe, including the relationship with the Company’s representative office in Stockholm for the Nordic markets and across Turkey. “We are delighted to appoint both Tegwen and Anne-Claire to these important leadership positions,” said Isabelle Dubots-Lafitte, chief executive officer of EMEA for OdysseyRe. “These appointments recognize their sign
LogicMonitor and Deutsche Telekom Expand Partnership Across Europe18.5.2026 09:00:00 CEST | Press release
Expanded availability of LogicMonitor within Deutsche Telekom’s managed services portfolio follows successful operational use in the UKSelect outcomes include reduced reporting times and proactive incident preventionExpansion extends across DACH, Benelux, and the Nordics LogicMonitor®, the AI-first platform for Autonomous IT, today announced the expanded availability of its platform within Deutsche Telekom’s managed services portfolio across selected European markets, including DACH, Benelux, and the Nordics. The expansion builds on operational use of LogicMonitor in the United Kingdom since 2023, where it has supported Deutsche Telekom’s service teams in improving visibility across network, cloud, and hybrid infrastructure environments. Experience gained from these deployments is now informing broader service enablement across additional European markets. As enterprise IT environments grow more complex, organisations require more than visibility—they need predictive resilience. Throug
Prokarium Reports Positive Interim Data from Phase 1/1b PARADIGM-1 trial of ZH9 in NMIBC patients, Demonstrating Excellent Safety and Encouraging Early Efficacy18.5.2026 09:00:00 CEST | Press release
ZH9 is very well tolerated with a favourable safety profile, and no dose-limiting toxicities or Grade ≥3 drug-related adverse events reported.ZH9 demonstrates 91% freedom-from-relapse in NMIBC patients who have reached study end.Company plans to run a larger phase 2 study across a range of patient populations spanning intermediate risk and high risk including CIS. Prokarium, a clinical-stage biopharmaceutical company pioneering bacterial immunotherapies for the treatment of solid tumours, today announced safety and antitumour efficacy results from an interim review of the ongoing Phase 1/1b PARADIGM-1 trial of ZH9 in non-muscle invasive bladder cancer (NMIBC) patients. These data were shared via an oral podium presentation at the American Urology Association (AUA26) Annual Meeting. Prokarium CMO, Dr Josefin-Beate Holz said “These data demonstrate ZH9 as a universally applicable treatment for patients. As the treatment is very well tolerated and is showing impactful outcomes for early a
VahatiCor Appoints Harry D. Rowland, Ph.D., as Chief Executive Officer18.5.2026 08:00:00 CEST | Press release
Endotronix co-founder and former CEO joins VahatiCor as the company advances the A-FLUX Reducer System® and the SERRA-I early feasibility study VahatiCor, Inc., a medtech company developing interventional therapies for Coronary Microvascular Dysfunction (CMD), announced today the appointment of Harry D. Rowland, Ph.D., as Chief Executive Officer. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260517830314/en/ VahatiCor CEO, Harry D. Rowland, Ph.D. Rowland previously served as Chief Executive Officer and President of Endotronix, where he led the development and commercialization of the Cordella™ Pulmonary Artery Sensor and Heart Failure System. Under his leadership, Endotronix raised over $150 million and grew to more than 150 employees. He also oversaw the PROACTIVE-HF pivotal trial from execution through FDA premarket approval and commercial launch. Following its acquisition by Edwards Lifesciences in 2024, Rowland stayed 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