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
Merz Aesthetics® Announces EU Approval of Two New Indications for Their Hyaluronic Acid Filler BELOTERO® Balance30.3.2026 22:49:00 CEST | Press release
Merz Aesthetics®, the world’s largest dedicated medical aesthetics business, is pleased to announce that BELOTERO® Balance has received EU approval for two additional indications: the treatment of infraorbital hollow (including the tear trough) and horizontal forehead lines1*. “With these new approvals, BELOTERO® Balance further strengthens its position as a versatile hyaluronic acid dermal filler, with a wide range of approved facial indications1 designed to integrate seamlessly within the skin and deliver predictable, harmonious aesthetic outcomes,” said Dr. Kerstin Olsson, Head of Medical Affairs EMEA. The approval of these two new indications is supported by compelling clinical evidence: In a clinical investigation on infraorbital hollow, 98.9% of subjects demonstrated visible improvement at Week 8, with long-lasting results sustained up to 72 weeks, and no treatment related serious adverse events reported.2 Similarly, in a postmarket investigation on horizontal forehead lines, 82.
Klarna Payments Now Available at B-Parts, Europe's Largest Automotive Parts Website30.3.2026 21:51:00 CEST | Press release
B-Parts is now offering its customers a more personalised and flexible shopping experience, with interest-free payments via "Pay in 3", amongst other Klarna features. Klarna, the global digital bank and flexible payments provider, is joining forces with B-Parts, a leading online retailer of used and original car parts, to offer consumers greater flexibility, convenience, choice and control at the point of payments, with no interest or hidden fees. Through Klarna’s interest-free installment payments, B-Parts customers will benefit from greater flexibility and control over their finances. Klarna also ensures a secure shopping experience thanks to its buyer protection scheme, as well as a range of features such as cashback and deals. "We continue to grow locally, with an increasing number of brands across different sectors recognising the enormous advantage of offering their customers more payment options, those that make for a more convenient and seamless checkout experience," explains I
Office of His Highness Sheikh Hamdan Bin Ahmed Al Maktoum Holdings & Gatbits IT Infrastructure Announce Launch of GTBS Digital Ecosystem; Mainnet Set for April 202630.3.2026 20:30:00 CEST | Press release
The Office of His Highness Sheikh Hamdan Bin Ahmed Al Maktoum Holdings, in collaboration with Gatbits IT Infrastructure, has officially announced the launch of the GTBS Digital Ecosystem, marking a significant step forward in the global Web3 space. The announcement follows the successful launch of the native GTBS Coin on December 25, with the ecosystem’s mainnet scheduled to go live in April 2026. GTBS represents a full-stack Web3 ecosystem integrating blockchain, artificial intelligence, decentralized finance (DeFi), entertainment, gaming, media, and cloud infrastructure into a unified platform. Built on the philosophy of “All Commitment On Time,” the ecosystem focuses on delivering reliability, scalability, and real-world utility. Designed as a comprehensive digital infrastructure, GTBS goes beyond standalone crypto platforms by offering an integrated environment for users, developers, creators, and enterprises. Its proprietary Layer-1 blockchain powers seamless interaction across se
Yubico Appoints Poupak Modirassari Enbom as Chief Marketing Officer to Accelerate Global Momentum and Drive Market Leadership30.3.2026 15:00:00 CEST | Press release
Yubico (NASDAQ STOCKHOLM: YUBICO), the creator of the most secure passkeys and a leading provider of hardware authentication security keys, today announced the appointment of Poupak Enbom as Chief Marketing Officer (CMO). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260330278027/en/ Enbom joins Yubico at a pivotal moment as organizations worldwide accelerate the shift to phishing-resistant authentication and modern identity security in the age of AI. “We’re excited to welcome Poupak to Yubico,” said Jerrod Chong, acting chief executive officer, Yubico. “As the threat landscape evolves with AI-driven attacks and increasing automation, organizations are rethinking how they secure digital identities of both humans and AI agents at scale. She brings a unique combination of technical depth, global leadership, and customer-first mindset that will help us continue to expand our impact and support our customers and partners around
Westinghouse Celebrates Record-breaking 80 Years of Nuclear Fuel Manufacture at Springfields30.3.2026 14:00:00 CEST | Press release
Fuel manufactured at Springfields has generated enough energy to supply the UK’s electricity demand for 26 years, avoiding the emission of nearly 3 billion tonnes of CO2 The Westinghouse Springfields facility in Lancashire, UK, has marked a significant milestone as the oldest continuous nuclear fuel manufacturing site in the world, starting from its original license on the 28th, March 1946. The site was chosen by the UK Government to develop nuclear fuel for the world’s earliest civil nuclear power stations, as well as subsequent Magnox and Advanced Gas Reactors (AGR) reactors. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260330135973/en/ From left to right: Sophie Lemaire; Marc Chevrel; Rory O'Neill; Craig Boothby; and Robert Gofton, CEO at Nuclear Institute Across the last eight decades, the Springfields site has supported the UK nuclear fleet, manufacturing more than eight million AGR pins, sintering and pressing over 5
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