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
BRUNO to Showcase Acclaimed Lifestyle and Travel Collections at Ambiente 20262.2.2026 09:00:00 CET | Press release
Tokyo-based lifestyle company BRUNO, Inc. (Headquarters: Shinjuku-ku, Tokyo; President & CEO: Tetsu Shiota), dedicated to the planning, development, and sale of lifestyle products, is pleased to announce its participation in Ambiente—the world’s leading international consumer goods trade fair held in Frankfurt, Germany. The company will showcase its two flagship brands: "BRUNO," a lifestyle brand dedicated to "enjoying life to the fullest," and "MILESTO," a premium travel brand designed for those who "live every day like a journey." This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260202663769/en/ Our participation in Ambiente marks a pivotal step in our global expansion strategy, as outlined in our current medium-term management plan. We are excited to introduce BRUNO and MILESTO—brands that have earned immense loyalty in Japan—to a global audience. Our exhibit showcases a curated selection of flagship products and latest inn
Reges Elektrik Acquires the Demirli Wind Power Plant, One of Türkiye’s Most Significant Wind Energy Projects2.2.2026 09:00:00 CET | Press release
Reges Elektrik, a dynamic and innovative leader in the Turkish energy sector, has announced the acquisition of Tuşpa Enerji Üretim A.Ş. as part of its strategic growth roadmap. Through this landmark acquisition, Reges Elektrik will launch electricity production at the 70 MW Demirli Wind Power Project, located in the Kaman district of Kırşehir. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260126059611/en/ From left to right: Enver Altuncu, General Manager and Board Member at Reges Elektrik; Cansu Ünal Öngören, CFO and Board Member at Reges Elektrik; Geert Dooms, General Manager at RES Türkiye; Kağan Gilik, Deputy General Manager at RES Türkiye. Acquired from RES Türkiye, a subsidiary of RES Group—the world’s largest independent renewable energy company—the Demirli Project represents a pivotal milestone in Reges Elektrik’s decisive expansion into energy production. With this investment, the company scales its operations to i
Teledyne FLIR Defense Wins $17.5 Million Contract from armasuisse to Deliver Black Hornet 4 Nano-Drones for Dismounted and Vehicle-Integrated Reconnaissance2.2.2026 08:00:00 CET | Press release
Delivery of the Black Hornet UAV systems to Swiss Armed Forces will include drones with software and integration kit specially designed to work with Piranha 8x8 vehicle digital infrastructureWork shows promise and market potential for UAS armored vehicle integrations to enhance tactical operations Teledyne FLIR Defense, part of Teledyne Technologies Incorporated (NYSE:TDY), announced that it has received a $17.5 million contract from armasuisse, the Swiss Federal Office of Defence Procurement, to deliver a large number of Black Hornet® 4 Personal Reconnaissance Systems, one of the world’s most advanced and widely deployed nano-drones. Black Hornet 4 was selected as an airborne dismountable Intelligence, Surveillance, and Reconnaissance (ISR) capability sensor for armasuisse’s Piranha 8x8 Armored engineering vehicle program. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260201061637/en/ Teledyne FLIR Defense has won a $17.5
Danish C-UAS Startup Shotling Raises €700K Oversubscribed Pre-Seed (Myriad-IPO CLUB-EIFO) for Anti-Drone Shotgun2.2.2026 07:35:00 CET | Press release
Shotling, a Danish defense technology startup specializing in kinetic short-range counter-UAS (C-UAS) systems, today announced the closing of a pre-seed financing round with €700K committed out of a targeted €500K. The round is led by Myriad Defense Fund, with co-investment from IPO CLUB’s Fund II America 2030, and a non-dilutive match-loan granted by EIFO, the Export and Investment Fund of Denmark, supporting Shotling’s mission to deliver rapid-fire modular shotgun systems against FPV drones and loitering munitions—as the global counter-UAS market accelerates towards $10B by 2030, with kinetic defense segment showing strong momentum (25%+ CAGR). Shotling’s rotary shotgun system provides unmatched close-range defense (50–100m) against the rapidly growing threat of kamikaze drones, combining a gatling-style design, with novel, high-capacity magazines, and firing rates up to 3,000 RPM using standard or tungsten-based 12-gauge shells. With deep expertise in weapons engineering and active
Galderma Announces U.S. FDA Acceptance of RelabotulinumtoxinA Biologics License Application Resubmission2.2.2026 07:00:00 CET | Press release
The United States (U.S.) Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) resubmission for RelabotulinumtoxinA for the temporary improvement of moderate-to-severe glabellar lines (frown lines) and lateral canthal lines (crow’s feet) in adults RelabotulinumtoxinA is designed to optimize molecule integrity to deliver fast onset of action as early as Day 1 and sustained results for six months for frown lines and crow’s feet and has been approved in over 20 markets, including in the European Union1-3 Galderma (SIX: GALD) today announced that the U.S. FDA has accepted the BLA resubmission for RelabotulinumtoxinA for the temporary improvement of moderate-to-severe glabellar lines (frown lines) and lateral canthal lines (crow’s feet) in adults. Galderma has worked closely with the U.S. FDA to implement adjustments to its manufacturing process. Galderma is committed to using its expertise and heritage in the neuromodulator space to develop next-generation
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