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
Ruler of Ras Al Khaimah Inaugurates the First Ras Al Khaimah’s Business Consultancy in China, Strengthening Ties With Guangdong21.10.2026 23:46:00 CEST | Press release
HH Sheikh Saud bin Saqr Al Qasimi, UAE Supreme Council Member and Ruler of Ras Al Khaimah, inaugurated the Emirate’s first business consultancy in China, marking a new chapter of cooperation and partnership. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261021542126/en/ His Highness Sheikh Saud bin Saqr Al Qasimi, UAE Supreme Council Member and Ruler of Ras Al Khaimah, inaugurated the Emirate’s first business consultancy in China, located in Guangzhou, Guangdong Province, stating that the launch reflects a long-term commitment to strengthening ties with partners in China and to creating new avenues for investment, trade and collaboration. (Photo: AETOSWire) Located in the industrial hub of Guangzhou, the consultancy will serve as a leading platform dedicated to strengthening Ras Al Khaimah’s engagement with Chinese businesses, facilitating expanding cooperation across key sectors. The inauguration builds on a relationship t
Octane AI Launches Phoenix, an AI Quiz Builder That Builds, Checks and Improves Quizzes for Shopify Brands21.10.2026 19:15:00 CEST | Press release
Phoenix builds a full quiz from a prompt or a document, catches broken logic before shoppers do and shows what every answer earns in Shopify revenue. Octane AI, the quiz and zero-party data platform for Shopify brands, launched Phoenix in October, its biggest release to date. Merchants describe the quiz they want or upload what they already have, and Phoenix builds it, checks it, personalizes the results and keeps improving it with experiments. One beta customer turned a single document into a complete product-launch quiz: “I attached it to Phoenix, and it built the whole thing, all the pages. It understood everything, not just the text but the logic behind it.” Across all live Octane AI quizzes, 15% of shoppers who finish a quiz place an order. Yet building one has meant hours of writing rules by hand, custom code for design and clicking through every path to find broken results. Phoenix handles those hard parts, from building a quiz to improving it after launch. “Since day one, we've
Cognite Earns Corporate Supplier of the Year Award from Marathon Petroleum Corporation21.10.2026 19:06:00 CEST | Press release
Cognite today announced it has been named Corporate Supplier of the Year winner in Marathon Petroleum Corporation’s 11th Annual Supplier Recognition Awards. The Supplier Recognition Awards is a program sponsored by Marathon Petroleum Corporation to honor suppliers that positively impacted the company’s business throughout the previous calendar year. “There’s a reason ‘Impact’ is one of Cognite’s most important core values,” said Girish Rishi, CEO of Cognite. “For us, the ultimate measure of our performance is delivering quantifiable value for our customers. From that perspective, the Corporate Supplier of the Year award from Marathon is particularly meaningful. Marathon Petroleum is an innovator, and to receive this recognition is a great honor to the Cognite community.” The Supplier of the Year Award from Marathon is the latest honor Cognite has received in 2026: In May, Cognite ranked 15th on CNBC’s Disruptor50 list, honoring venture-backed companies innovating across industries, exp
The Estée Lauder Companies Inc. to Webcast Capital Markets Experience: China Ecosystem Immersion Presentations on November 4, 202621.10.2026 18:48:00 CEST | Press release
The Estée Lauder Companies Inc. (NYSE: EL) today announced that it will webcast presentations from its Capital Markets Experience: China Ecosystem Immersion in Shanghai, China, on Wednesday, November 4, 2026. The event will feature presentations from Stéphane de La Faverie, President and Chief Executive Officer, and Akhil Shrivastava, Executive Vice President and Chief Financial Officer, as well as members of the Company’s Executive Leadership Team and local leaders. The presentations will highlight the Company’s strategy and capabilities in China, Beauty Reimagined in action, and how China serves as a blueprint for deploying the Company’s global capabilities to drive sustainable growth and stronger profitability. Due to limited capacity, in-person attendance is by invitation only. Interested parties can access the live webcast on Wednesday, November 4th, beginning at 1:00 p.m. China Standard Time (12:00 a.m. ET) at Investors – The Estée Lauder Companies Inc. A replay of the webcast wi
Future Health and Bridge for Billions to Launch Programme Strengthening Health Entrepreneurship in Emerging Markets21.10.2026 17:50:00 CEST | Press release
New programme will support locally rooted health entrepreneurs to build stronger ventures and deepen their impact in the communities they serve The programme responds to persistent gaps in capital and specialist support for promising health innovation across emerging markets First phase will target around 50 entrepreneurs leading late-incubation to early-acceleration ventures in Africa and Asia Entrepreneurs will receive tailored support, with selected groups later having the opportunity to access Abu Dhabi’s health innovations ecosystem Future Health – A Global Initiative by Abu Dhabi and Bridge for Billions will launch a new entrepreneurship programme designed to strengthen promising health ventures in emerging markets and help locally-developed solutions reach more people. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261021719421/en/ The first phase of the programme will target around 50 entrepreneurs leading late-incub
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