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
Acceleronix, IDEMIA Secure Transactions and Orange Announce Flexible, Single-SKU Manufacturing with Quantum-Safe IFPP4.11.2026 16:44:00 CET | Press release
One SKU. Every market. Connectivity decided at the end of production. Live at electronica 2026. Orange, one of the world’s leading telecom operators, has joined the global quantum-safe In-Factory Profile Provisioning (IFPP) program, jointly launched by Acceleronix and IDEMIA Secure Transactions at MWC Barcelona in February. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261104070181/en/ Acceleronix, IDEMIA Secure Transactions and Orange announce flexible, single-SKU manufacturing with quantum-safe IFPP The program enables device makers to build a single product for every market and connect it to the Orange network before it leaves the factory. Acceleronix and IDEMIA Secure Transactions will demonstrate the solution live at electronica 2026, the international electronics trade fair, at Messe München, Hall C2, Stand 601, from 10 to 13 November. Most connected devices share the same weak spot: provisioning and testing on the pr
U.S. FDA Grants Priority Review to BeOne Medicines’ BRUKINSA Combination in First-Line Mantle Cell Lymphoma4.11.2026 15:13:00 CET | Press release
If approved, BRUKINSA plus rituximab would be the first and only chemotherapy-free, BTK inhibitor-based regimen for adult patients with previously untreated mantle cell lymphomaApplication supported by Phase 3 MANGROVE data, showing a 43% reduction in the risk of progression or death versus bendamustine plus rituximabFull MANGROVE results to be presented during the Plenary Scientific Session at the 68th American Society of Hematology Annual Meeting BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review to the supplemental New Drug Application (sNDA) for BRUKINSA® (zanubrutinib) in combination with rituximab for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL). The application is supported by data from the pivotal Phase 3 MANGROVE study, in which this chemotherapy-free regimen significantly reduced the risk of dis
Rimini Street Awarded CANUT Third-Party Maintenance Framework Agreement4.11.2026 15:00:00 CET | Press release
This framework agreement provides all entities subject to the French Public Procurement Code with simplified access to a support alternative enabling them to control their costs, preserve their freedom of technological choice and free themselves from vendor-imposed upgrade cycles Rimini Street, Inc. (Nasdaq: RMNI), the Software Support and Agentic AI ERP Company™ and the leading third-party support provider for Oracle, SAP and VMware software, today announced that it had been selected as the awardee of the third-party support service lots (TMA) by CANUT, the French public purchasing center specializing in digital technology and telecommunications. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261104431817/en/ Rimini Street Awarded CANUT Third-Party Maintenance Framework Agreement Eligible public organizations subject to the French Public Procurement Code can now benefit from Rimini Street services for their Oracle, SAP, VMw
Incyte to Present New Data Highlighting Progress Across its Hematology Portfolio at ASH 20264.11.2026 15:00:00 CET | Press release
New data in myeloproliferative neoplasms (MPNs) will include INCA033989, Incyte’s first-in-class, mutant calreticulin (mutCALR)-targeted monoclonal antibody, in first-line myelofibrosis (MF); and preclinical findings for Incyte’s next-generation mutCALR- and JAK2V617F-targeted compoundsUpdated results for INCA033989 in second-line MF and second-line essential thrombocythemia (ET) will build on previously presented datasetsLong-term Phase 1/2 data further characterize the potential of latarcibart (VGA039), an investigational Protein S-targeting antibody, as prophylaxis in adolescents and adults with von Willebrand disease (VWD)More than 30 abstracts will highlight progress across Incyte’s broader hematology portfolioIncyte will host an investor event and webcast on Saturday, December 12, 2026 from 7:30 – 9:00 p.m. CT (8:30 – 10:00 p.m. ET) Incyte (Nasdaq:INCY) today announced that new data highlighting progress across its hematology portfolio will be presented across more than 30 abstra
Zenitar Announces Initiation of International Randomized Study of Flonoltinib Maleate in Patients with Myelofibrosis and Related American Society of Hematology 2026 Meeting Presentations4.11.2026 15:00:00 CET | Press release
Chengdu Zenitar Biomedical Technology Co., Ltd. (Zenitar) is developing flonoltinib maleate (FM), a first-in-class oral JAK2/FLT3/CDK6 inhibitor for myeloproliferative neoplasms (MPNs), including myelofibrosis (MF) and polycythemia vera (PV). Zenitar launched randomized Phase 2 FM-MF-02 (NCT07750574) in the US, Canada and Brazil to select Phase 3 dose for JAKi-naïve and refractory MF. Randomized FMF-02 (NCT06457425) met its week-24 endpoints: superior SVR35 and TSS50 with FM 50/100mg versus ruxolitinib; previous data presented orally at ASH24 (#486) and ASH25 (#908). ASH 2026 presence covers FMF-02 long-term follow-up (oral presentation, #411, December 12, 4:30pm) and refractory PV Phase 2 data (poster, #3765, December 13, 6pm), both in Session 634. “Over the 15 years since the initial FDA approval of Ruxolitinib, JAKi have markedly improved the prognosis of many patients with MF. The long-term data show significant room for improvement for this key therapeutic class in terms of both e
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