VIFOR-PHARMA-GROUP
27.9.2021 08:04:09 CEST | Business Wire | Press release
Vifor Fresenius Medical Care Renal Pharma (VFMCRP) today announced that Japan’s Ministry of Health and Labor Welfare (MHLW) has granted its partner, Kissei Pharmaceutical Co., Ltd., marketing authorization approval for TAVNEOS® for the treatment of patients with granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA), the two main types of ANCA-associated vasculitis, a rare and severe autoimmune renal disease with high unmet medical need.
“We are delighted that TAVNEOS® has been approved in Japan, the first market worldwide, and congratulate our partner Kissei for this significant milestone,” said Abbas Hussain, CEO of Vifor Pharma Group. “ANCA-associated vasculitis is officially designated an intractable disease in Japan, indicating a rare disease without any effective treatment but for which long-term treatment is required. There is significant unmet medical need of over 10,000 patients in Japan, and we believe in the potential of TAVNEOS® for treating it. We are confident that Kissei will fully focus on bringing this breakthrough treatment to this patient population, helping them lead better, healthier lives.”
The approval is based on the marketing authorization application filing by Kissei which was supported by positive clinical data from the pivotal phase-III trial ADVOCATE in a total of 331 patients with MPA and GPA in 18 countries and regions, including Japan. TAVNEOS® demonstrated superiority over standard of care at week 52 based on Birmingham Vasculitis Activity Score (BVAS).
VFMCRP holds the rights to commercialize TAVNEOS® outside the U.S.. In June 2017, VFMCRP granted Kissei the exclusive right to develop and commercialize TAVNEOS® in Japan. Kissei expects to begin to market TAVNEOS® as soon as possible following NHI price listing. Outside Japan, TAVNEOS is currently in regulatory review with various agencies, including the U.S. Food and Drug Administration and the European Medicines Agency.
About Vifor Pharma Group
Vifor Pharma Group is a global pharmaceuticals company. It aims to become the global leader in iron deficiency, nephrology and cardio-renal therapies. The company is a 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 and Vifor Fresenius Medical Care Renal Pharma (a joint company with Fresenius Medical Care). 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 viforpharma.com .
About Kissei Pharmaceutical Co., Ltd.
Kissei Pharmaceutical Co., Ltd. is a Japanese pharmaceutical company with approximately 70 years of history. Based on its management philosophy, “contributing to society through high-quality, innovative pharmaceutical products” and “serving society through our employees”, Kissei is concentrating on providing innovative pharmaceuticals to patients worldwide as a strongly R&D-oriented corporation. Kissei is engaged in R&D and licensing activities in the field of nephrology/dialysis, urology, and unmet medical needs in other disease areas. Kissei has an established collaboration with VFMCRP for sucroferric oxyhydroxide which Kissei fully developed in Japan as P-TOL® (known as Velphoro® in Europe/US) for the treatment of hyperphosphatemia. Since the launch in 2015, the market share of P-TOL® has been steadily expanding in Japan. For more information about Kissei Pharmaceutical, please visit www.kissei.co.jp .
About ChemoCentryx Inc.
ChemoCentryx is a biopharmaceutical company developing new medications for inflammatory and autoimmune diseases and cancer. ChemoCentryx targets the chemokine and chemoattractant systems to discover, develop and commercialize orally-administered therapies. Besides ChemoCentryx’s lead drug candidate, avacopan, ChemoCentryx also has early stage drug candidates that target chemoattractant receptors in other inflammatory and autoimmune diseases and in cancer.
About ANCA-associated vasculitis
ANCA-associated vasculitis is a systemic disease in which over-activation of the complement pathway further activates neutrophils, leading to inflammation and destruction of small blood vessels. This results in organ damage and failure, with the kidney as the major target, and is fatal if not treated. Currently, treatment for ANCA-associated vasculitis consists of courses of non-specific immuno-suppressants (cyclophosphamide or rituximab), combined with the administration of daily glucocorticoids (steroids) for prolonged periods of time, which can be associated with significant clinical risk including death from infection.
About TAVNEOS® (avacopan)
Avacopan is an orally-administered small molecule that is a selective inhibitor of the complement C5a receptor C5aR1. By precisely blocking the receptor (the C5aR) for the pro-inflammatory complement system fragment, C5a on destructive inflammatory cells such as blood neutrophils, avacopan arrests the ability of those cells to do damage in response to C5a activation, which is known to be the driver of inflammation. Moreover, avacopan’s selective inhibition of only the C5aR1 leaves the beneficial C5a l pathway through the C5L2 receptor functioning normally.
ChemoCentryx is also developing avacopan for the treatment of patients with C3 Glomerulopathy (C3G) and hidradenitis suppurativa (HS). The U.S. Food and Drug Administration has granted avacopan orphan-drug designation for ANCA-associated vasculitis, C3G and atypical hemolytic uremic syndrome. The European Commission has granted orphan medicinal product designation for avacopan for the treatment of two forms of ANCA vasculitis: microscopic polyangiitis and granulomatosis with polyangiitis (formerly known as Wegener's granulomatosis), as well as for C3G. In October 2020, European Medicines Agency (EMA) accepted to review the Marketing Authorization Application (MAA) for avacopan for the treatment of patients with ANCA-associated vasculitis (granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA)).
View source version on businesswire.com: https://www.businesswire.com/news/home/20210926005078/en/
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
Daiichi Sankyo Europe Reaffirms Commitment to Patient-Centred Care with Extensive Data Showcase at EAS Congress 202626.5.2026 17:00:00 CEST | Press release
Presentations at the 94th European Atherosclerosis Society (EAS) Congress highlight the breadth of evidence for bempedoic acid across a wide range of patient subgroups and background therapies. Real-world data from the MILOS study across multiple European cohorts demonstrate consistent effectiveness and safety profile in routine clinical practice.1,2,3,4 Analysis from the CLEAR Outcomes trial underscores the impact of bempedoic acid on cardiovascular risks, including stroke and venous thromboembolism (VTE).5,6 Daiichi Sankyo Europe’s commitment to "care for every heartbeat" is centred on providing accessible oral treatment options to ensure every patient is given a chance to reach their LDL-C goals. Daiichi Sankyo Europe (DSE) is pleased to announce its extensive scientific presence at the European Atherosclerosis Society (EAS) Congress 2026. The presentation of 15 abstracts, comprising both clinical trial analyses and real-world evidence, underscores the company's sustained investment
OpenRouter Raises $113 Million CapitalG-led Series B as Weekly Volume Explodes to 25T Tokens26.5.2026 15:15:00 CEST | Press release
NVentures, ServiceNow Ventures, MongoDB Ventures, Snowflake Ventures, Databricks Ventures join CapitalG, a16z, Menlo Ventures, and others in backing the high-growth AI infrastructure startup OpenRouter, the AI model exchange, today announced a $113 million Series B led by Alphabet’s independent growth fund, CapitalG, with participation from investors including NVentures (NVIDIA’s venture capital arm), ServiceNow Ventures, MongoDB Ventures, Snowflake Ventures, Databricks Ventures, alongside existing investors including Andreessen Horowitz and Menlo Ventures. OpenRouter’s volume has surged to 25 trillion tokens per week (100 trillion tokens per month), representing a 5X increase from the 5 trillion tokens processed per week just six months ago. The explosion in token demand illustrates how quickly enterprises are deploying agents and scaling AI across multiple models and providers. OpenRouter’s infrastructure manages and optimizes inference and provides access to 400+ models across leadi
Xsolla Expands Its Community Management Tools for Creators, Community Leaders, and Resellers26.5.2026 15:00:00 CEST | Press release
Xsolla Adds New Features For Creators, Community Leader Experience, And Distinct Channels For Emerging Markets Xsolla, a leading global video game commerce company, today announced three simultaneous expansions of its community management tools and products. As the creator economy continues to reshape how games are discovered and the industry accelerates its shift toward direct-to-consumer commerce, Xsolla is building on its community management tools for creators, community leaders, and emerging markets, and will showcase them at TwitchCon Rotterdam later this month. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260526596720/en/ Graphic: Xsolla The games industry has never had a shortage of people who drive player acquisition, loyalty, and commerce; it's had a shortage of infrastructure that recognizes them. Creators stream it. Community leaders build a culture around it. Local resellers get it into the hands of players in
Biocytogen Launches AI-Powered RenSuper™ Platform and Industry-First Fully Automated Antibody Discovery Infrastructure26.5.2026 14:00:00 CEST | Press release
Biocytogen today announced the launch of RenSuper Workstation, a next-generation AI-powered antibody discovery platform providing off-the-shelf access to a large-scale, experimentally validated library of fully human therapeutic antibody sequences, together with the RenSuper High-Throughput Antibody Manufacturing Automation Center, a fully automated infrastructure designed to accelerate antibody validation and production. Built on Biocytogen’s proprietary RenMice® platforms, RenSuper establishes a closed-loop antibody discovery engine combining in vivo immune repertoires, AI-driven candidate selection, automated experimental validation, and scalable manufacturing infrastructure. The platform supports the discovery and development of monoclonal antibodies, bispecifics, multispecifics, antibody-drug conjugates (ADCs), VHHs, and other advanced therapeutic modalities, significantly reducing the time and risk associated with antibody discovery. RenSuper Workstation: AI-Powered One-Click Tar
ViaLase Announces Global Commercial Introduction of the FLIGHT Procedure26.5.2026 14:00:00 CEST | Press release
First commercial femtosecond laser image-guided, high precision trabeculotomy (FLIGHT) treatments mark a new era in interventional glaucoma; one where precision, safety, and the patient experience define the new standard of care ViaLase, Inc., a commercial stage medical technology company pioneering incision-free, laser-based solutions for glaucoma, today announced the successful completion of the first commercial FLIGHT procedures performed at Centre for Sight in London by Sheraz Daya, MD, and Gus Gazzard, MD, and at Breyer, Kaymak & Klabe Augenchirurgie in Düsseldorf, Germany, by Karsten Klabe, MD. The first commercial FLIGHT procedures were performed using the ViaLuxe® Laser System to deliver an incision-free, image-guided femtosecond laser treatment designed to create precise channels through the trabecular meshwork to restore aqueous outflow and reduce intraocular pressure in patients with open-angle glaucoma. “Centre for Sight has always been committed to bringing meaningful inno
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