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
BeOne Medicines’ Foundational Hematology Franchise Leads Next Era of B-Cell Cancer Innovation at EHA 202612.6.2026 12:00:00 CEST | Press release
Tacabrutideg (BGB-16673, BTK degrader) showed durable responses in heavily pretreated R/R CLL and BTK inhibitor–naïve patients, signaling potential for earlier lines of treatmentBRUKINSA plus sonrotoclax (ZS) delivered deep, durable responses and high uMRD rates across TN CLL and R/R MCL and CLL, reinforcing its potential as an all-oral, fixed-duration treatment BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced new data from its foundational hematology franchise at the 2026 European Hematology Association (EHA) Congress in Stockholm. Updated results from tacabrutideg (BGB-16673), a potential best-in-class Bruton’s tyrosine kinase (BTK) degrader, demonstrated durable responses in pretreated relapsed/refractory (R/R) chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), with early activity also seen in BTK inhibitor–naïve patients. These data are complemented by results from the all-oral combination of BRUKINSA® (zanubru
Cyviz: Microsoft’s Immersive Approach to Collaboration12.6.2026 09:00:00 CEST | Press release
At Microsoft’s Innovation Hub in Amsterdam, immersive technology is used to enable co-creation rather than one-way presentations. In the company’s Immersive Suite, customers, data experts, and technology specialists come together in a shared environment to address complex challenges more effectively. Watch Video Case Study >> This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260612831180/en/ Watch Video Case Study >> https://www.cyviz.com/case-studies/microsoft-immersive-suite/ As business and technology environments grow more complex, establishing shared understanding across disciplines has become critical. The Immersive Suite is designed for active collaboration, where visual narratives, data, and technical content are explored interactively. This allows participants to test scenarios, align perspectives, and move more efficiently from discussion to decision. “We deliberately work with familiar tools like PowerPoint. That all
LTM Launches AI 1000 to Develop the Next Generation of Forward Deployed Engineers12.6.2026 08:14:00 CEST | Press release
LTM, the Business Creativity partner to the world’s largest enterprises, today announced AI 1000, a strategic workforce transformation initiative anchored by a dedicated Center of Excellence (CoE). The program will develop a pool of 1,000+ AI-certified engineers, including Forward Deployed Engineers (FDEs), to help enterprises adopt, deploy, and scale AI. The launch comes amid a major shift in enterprise tech talent. The FDE — among the fastest-growing roles in the AI ecosystem — combines the technical knowledge of LLMs and domain SLMs with business understanding to turn ideas into quantifiable ROI accretive outcomes and to drive client adoption. AI 1000 is LTM’s structured response to this shift: it provides the training, platforms, and governed career frameworks to develop FDEs at scale. AI 1000 takes an end-to-end approach to talent development via a four-stage model: Identify, Enable, Deploy, and Govern. It starts by identifying high-potential engineers using a proprietary AI Readi
NTT DATA Group Appoints Kazuhiko Nakayama as New President and Chief Executive Officer12.6.2026 08:00:00 CEST | Press release
Kazuhiko Nakayama appointed President and CEO of NTT DATA Group; Yutaka Sasaki to become Senior Executive Vice President of NTT, Inc. NTT DATA Group, a global leader in AI, digital business and technology services, today announces that the Board of Directors has approved the appointment of Kazuhiko Nakayama as NTT DATA Group’s new President and Chief Executive Officer, effective June 12, 2026. Yutaka Sasaki, former President and CEO of NTT DATA Group, will assume the role of Senior Executive Vice President of NTT, Inc., effective June 18. Serving most recently as CFO of NTT DATA Group, Nakayama brings proven leadership and a depth of expertise and experience in defining business strategy and delivering growth. He will continue to strengthen the competitive advantages of the $30+ billion business whilst accelerating it’s AI-centered growth strategy across the 70+ countries and regions in which it operates. NTT DATA Group’s growth strategy will focus on two key areas alongside its core b
Venture Global Announces Closing of $2.25 Billion of Senior Secured Notes11.6.2026 23:00:00 CEST | Press release
Venture Global LNG, Inc. (“Venture Global”) announced today that its wholly-owned subsidiary, Venture Global LNG, Inc. (the “Issuer”) has closed its offering of $1.125 billion aggregate principal amount of its 6.375% senior secured notes due 2034 (the “2034 Notes”) and $1.125 billion aggregate principal amount of its 6.625% senior secured notes due 2036 (the “2036 Notes” and, together with the 2034 Notes, the “Notes”). The Issuer used the gross proceeds from the offering to redeem all of the Issuer’s outstanding 8.125% senior secured notes due 2028 (the “Existing 2028 Notes”) and used cash on hand to pay the redemption premium and related fees and expenses for the offering and the redemption. The 2034 Notes will mature on December 15, 2034, and the 2036 Notes will mature on June 15, 2036. The Notes were issued at par. The Notes will initially not be guaranteed by any of the Issuer’s subsidiaries. In the future, certain of the Issuer’s subsidiaries that incur or guarantee certain amount
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