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
NIPPON KINZOKU Accelerates Global Sales of Ultra-Thin Electrical Steel Strips "GT Series" and "ST Series" as "Fine Eco Metal" Environmentally Friendly Products9.7.2026 10:01:00 CEST | Press release
- Delivering the ultimate balance of “Ultra-Thinness” and “Low Core Loss” to drastically reduce high-frequency energy loss - NIPPON KINZOKU CO., LTD. (Headquarters: Minato-ku, Tokyo; President: Yasushi Shimokawa; TOKYO: 5491) and its subsidiary, NIKKIN DENJI KOGYO CO., LTD. (Headquarters: Kawaguchi, Saitama; President: Akira Nishimura), are launching a strategic sales initiative for their ultra-thin Grain-Oriented (GT Series) and Non-Oriented (ST Series) electrical steel strips under the brand name "Fine Eco Metal". This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260709899733/en/ By reducing the thickness of the electrical steel strip, eddy current loss (core loss) can be significantly lowered. Eddy currents are electrical currents generated within the electrical steel strip by alternating magnetic fields; they are a primary factor that increases core loss. "Fine Eco Metal" is a brand name for our proprietary "Eco-Product" se
3E Acquires Yordas Group: Expanding Leadership in Product Compliance by Augmenting 3E’s Global Regulatory Content and Expertise, and Adding REACH Registration Services9.7.2026 10:00:00 CEST | Press release
3E, the leading global provider of expert-led AI compliance solutions for chemical and workplace safety, product stewardship, and sustainable supply chains, today announced its acquisition of Yordas Group, a leading international provider of scientific consulting and regulatory content services across chemical management, product stewardship, sustainability, and regulatory compliance. Headquartered in Lancaster, UK, with operations in Germany, Canada, Türkiye, and Japan, Yordas serves global brands through its Scientific Services, Regulatory Intelligence, Product Compliance, and Hazard Communication offerings. Solidifying 3E’s Global Regulatory Content Leadership and Breadth of Expertise The acquisition extends 3E's regulatory content leadership and joins two organizations that pride themselves on building and aligning the industry’s top talent of advanced regulatory and chemical experts. It further solidifies 3E as the product compliance solution provider with the industry's broadest
ROYC and PwC Sweden Collaborate to Digitalize Private Equity Structuring & Fund Operations9.7.2026 10:00:00 CEST | Press release
ROYC today announces a strategic collaboration with PwC Sweden to accelerate the digitalization of the GP value chain. The partnership brings together PwC Sweden's market-leading expertise in fund formation and structuring with ROYC’s platform capabilities, with the shared aim of compressing time-to-market, eliminating manual friction in early-phase workflows, and improving the client experience across the full fund lifecycle for fund managers operating across any jurisdiction. "Digitalization of fund operations is overdue. We work alongside fund managers on structuring decisions, regulatory requirements, and operational complexity every day, and the inefficiencies in the early phase are real and costly. What excites me about this collaboration is the practical ambition behind it: taking the knowledge we apply manually today and making it available through a platform that GPs can use from day one. Working directly with the ROYC team in Stockholm makes iteration fast, and the applicatio
Hytera Introduces PDC580 Dual-Mode Rugged Radio to Support Seamless Communication Across Critical Operations9.7.2026 09:25:00 CEST | Press release
Hytera, a leading global provider of critical communications technologies and solutions, announced the launch of the PDC580 Dual-Mode Rugged Radio, developed for organizations that continue to rely on PMR while expanding broadband communications across increasingly distributed operations. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260708879078/en/ Built to connect LTE and PMR, the Hytera PDC580 brings dual-mode communication into one compact rugged radio. “The transition from narrowband to broadband is not an overnight replacement,” said Arthur Luo, Product Manager of Hytera Smart Terminal BU. “Many organizations will operate mixed communication environments for years to come. The PDC580 is designed to make that transition seamless, allowing teams to stay connected without changing established operational workflows.” Many frontline operations involve personnel working across different locations, departments, and network
LR Invests Over €2 Million in Quality and Growth9.7.2026 09:00:00 CEST | Press release
Global demand for innovative health products continues to grow, and with it the requirements for quality, supply reliability and production capacity. LR Health & Beauty is therefore strengthening its Ahlen headquarters with an investment of more than €2 million, laying the foundation for further growth. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260709000261/en/ New, state-of-the-art production line in Ahlen, Germany, manufacturing LR 5in1 Beauty Elixir and LR 5in1 Men's Shot. At the heart of the investment is a new, state-of-the-art production line. LR will use it to fully consolidate the manufacturing of its successful 5-in-1 products at its Ahlen headquarters. This includes, among others, the LR 5in1 Beauty Elixir and the LR 5in1 Men’s Shot. At the same time, the new facility creates the conditions for future product innovations in modern nutritional supplement concepts. By bringing the complete production of its 5-in
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