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
Lehman Brothers Treasury Considers Sale and Final Wind-Down3.8.2026 15:30:00 CEST | Press release
Lehman Brothers Treasury Co. B.V. in liquidation (“LBT”) today, through its U.S. counsel Herbert Smith Freehills Kramer (USA) LLP, announced that LBT is considering a final wind-down of its estate. In connection therewith, LBT has retained Seaport Loan Products LLC as its exclusive placement agent in connection with the potential sale of LBT’s principal remaining asset – a $19.6 billion Class 4A allowed claim against Lehman Brothers Holdings Inc. (the “LBHI Claim”). LBT expects the sale to occur, if at all, in August 2026. To the extent the LBHI Claim is sold, LBT expects to make a final distribution to the holders of its existing notes and thereafter facilitate the cancellation of those notes and the final wind down of its estate in September 2026. The foregoing is subject to further consents and authorizations and LBT retains sole discretion to abandon or otherwise discontinue any sale process at any time. Accordingly, there can be no assurances that the sale process will be conducte
ClickHouse Launches ClickHouse Labs With Andy Pavlo as VP of Database Research3.8.2026 15:30:00 CEST | Press release
Renowned database researcher will lead a new group dedicated to advancing foundational database technology and sharing its work openly with the broader community ClickHouse today announced the launch of ClickHouse Labs, a new research group led by Andy Pavlo, one of the database industry’s most prominent researchers. Dr. Pavlo joins ClickHouse as Vice President of Database Research and will build a team dedicated to advancing the state of the art in database systems. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260803890510/en/ Andy Pavlo, VP of Database Research, ClickHouse Pavlo is an award-winning database researcher and professor at Carnegie Mellon University’s Computer Science Department. He is known throughout the database community for his work on autonomous databases, transaction processing, and large-scale data analytics. At ClickHouse, he will bring that expertise to some of the most ambitious and consequential c
EuroTeleSites Strengthens Operations One Year into Sitetracker Partnership3.8.2026 15:00:00 CEST | Press release
EuroTeleSites, one of Central and Eastern Europe's leading independent tower companies, today announced the results of its first year in partnership with Sitetracker, the leading global Asset Lifecycle Management platform. One year into the deployment, EuroTeleSites reports meaningful progress in its digital transformation, with measurable improvements in operational efficiency, cross-market transparency, and project coordination across its six-country footprint. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260727009809/en/ EuroTeleSites Strengthens Operations One Year into Sitetracker Partnership Driving Efficiency in a Complex, High-Investment Environment EuroTeleSites invests approximately 25% of its revenue into capital expenditures in 2026, funding the construction and upgrade of tower infrastructure across Central and Eastern European markets. Managing this level of scale and complexity demands robust digital support
Visa to Acquire BioCatch3.8.2026 14:30:00 CEST | Press release
BioCatch’s behavioral and device intelligence expertise expected to help detect scams, account takeovers and digital fraud before they happen Visa (NYSE: V) today announced it has signed a definitive agreement to acquire BioCatch, a leading provider of behavioral-first, multi-signal fraud intelligence, from funds advised by Permira and other shareholders for $2.4 billion in cash. The acquisition of BioCatch complements Visa’s existing cyber, fraud, risk and security solutions and is expected to help clients better protect themselves and their customers from the growing threat of account takeovers, scams, money mules and application fraud. Since its inception, BioCatch has developed innovative AI and machine learning-based solutions that analyze thousands of application, behavioral, device, and network signals—such as keystrokes, touch gestures, and device handling—to detect fraud and distinguish legitimate users from fraudsters in real time. BioCatch protects 1.8 billion devices and 76
U.S. Bank Investment Services enhances investor and client onboarding experience for alternative investments3.8.2026 14:16:00 CEST | Press release
U.S. Bank Investment Services today announced it has gone live with a new client lifecycle management (CLM) platform, providing a comprehensive onboarding solution for alternative investment clients and the investors in their funds. The implementation is a key milestone in Investment Services’ multi-phased technology transformation strategy, aimed at modernizing processes, workflows and reporting across the private funds space. U.S. Bank leverages CLM provider Fenergo and its Fen-X platform. Fen-X automates many of the manual processes traditionally associated with underlying investors and direct client relationships and accelerates account setup while maintaining regulatory requirements. The enhanced onboarding experience provides investors and clients with more transparency throughout the process and enables integration with other solutions providers involved in the investor journey, such as screening and tax reporting. The investor experience has been further enhanced with an invest
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