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
Grindr for Equality Commits to Connecting 10M to HIV Prevention by 202827.7.2026 16:31:00 CEST | Press release
New report finds PrEP awareness is high but access is low, as global HIV funding shrinks Grindr steps up Today at the 2026 International AIDS Conference, Grindr for Equality committed to connecting ten million LGBTQ+ people to HIV prevention by 2028, leveraging its platform reach to advance the global effort to end HIV by 2030. The commitment is rooted in Closing the Gap, a new Grindr for Equality report drawing on survey data from Grindr users across ten countries. The central finding is consistent across countries: people know about PrEP but they are not taking it. The barrier is access and the funding that existed to address it is disappearing. "Connecting people is what Grindr does at a scale and in communities that traditional public health systems don't effectively reach," said George Arison, CEO and Chairman of Grindr (NYSE: GRND). "The global HIV response is losing critical funding at the exact moment we should be accelerating to end HIV by 2030. Grindr has the reach and the re
InterSystems Launches Data Studio AI Assistant to Accelerate Enterprise Data Exploration and Insights27.7.2026 16:00:00 CEST | Press release
New Generative AI extension simplifies how teams explore, analyze, and visualize enterprise data InterSystems, a creative data technology provider powering some of the world's most important applications, today announced the general availability of InterSystems Data Studio™ AI Assistant, a new generative AI-powered extension for InterSystems Data Studio that helps organizations more easily understand, navigate, query, and visualize data through natural language interactions. As organizations move from AI experimentation to production deployments, many are discovering that the greatest challenge is not the AI model itself, but providing AI systems with access to trusted, current, and business-ready information. Enterprise data is often fragmented across applications, databases, cloud services, files, data warehouses, and departmental silos, making it difficult for users and AI systems to generate reliable insights. “Organizations are increasingly looking for ways to turn their data into
PMI U.S. Opens $1.2 Billion Aurora Campus, Strengthening U.S. Manufacturing and Export Capabilities27.7.2026 14:00:00 CEST | Press release
Landmark investment advances U.S. manufacturing leadership, creates high-quality jobs, and positions the Colorado location as a strategic production and export hub Philip Morris International Inc.’s (PMI) (NYSE: PM) U.S. businesses (PMI U.S.) today celebrated the opening of its Aurora, Colorado manufacturing campus, a landmark investment representing total capital expenditures of $1.2 billion from 2024-2028. The campus expands the company’s domestic manufacturing capabilities, strengthens supply chain resilience, and positions Aurora as a strategic production and export hub supporting future growth. The site began commercial production in July 2026 and produces ZYN nicotine pouches, joining PMI U.S.’s growing modern nicotine manufacturing network, which includes operations in Owensboro, Kentucky, and Wilson, North Carolina. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260727514086/en/ PMI U.S. Opens $1.2 Billion Aurora Cam
Tecnotree Strengthens LATAM Growth with New Digital Transformation Contracts Worth USD 8.8 Million27.7.2026 13:20:00 CEST | Press release
Tecnotree, a global leader in AI-native Digital Business Support Systems (BSS) and digital platform solutions, today announced it has secured new digital transformation contracts across Latin America with a combined value of USD 8.8 million, reinforcing the company’s continued commercial momentum and expanding its presence across one of its key strategic growth markets. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260727931342/en/ Tecnotree Strengthens LATAM Growth with New Digital Transformation Contracts Worth USD 8.8 Million Across the engagements, Tecnotree will deploy its AI-native digital platform and B2B Marketplace for enterprises to simplify customer and business operations through intelligent digital engagement, real-time monetization, digital commerce and partner ecosystem management and AI driven marketing and experience management. By providing a unified digital foundation, the platform enables communications
Pure Lithium Corporation Appoints Mercedes-Benz Battery Veteran Dr. Tobias Glossmann as Chief Product Officer27.7.2026 13:00:00 CEST | Press release
Pure Lithium Corporation, a vertically integrated next-generation lithium metal battery company and developer of the patented Brine to Battery™ technology, today announced the appointment of Dr. Tobias Glossmann as Chief Product Officer. In this role, Dr. Glossmann will lead product and technology strategy, guiding the translation of Pure Lithium’s battery science into engineered products and directing the company’s product engineering efforts. Dr. Glossmann joins Pure Lithium after a 25-year career across Mercedes-Benz companies, most recently serving as Principal Systems Engineer at Mercedes-Benz Research & Development North America. His work spanned advanced battery technology development, from materials through complete battery systems, and he held companywide responsibility for high voltage safety. His career began in 2001 with battery systems development at DaimlerChrysler in Ulm, Germany, and later in Michigan, giving him more than two decades of experience across cell chemistry
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