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
3D Systems Achieves Full-Scope EU MDR Certification, Accelerating European Launch of NextDent® Jetted Denture Solution Targeted for Summer 202625.3.2026 17:20:00 CET | Press release
Certification Marks Major Milestone in Strategic Dental Growth Initiative Addressing Straightening, Protection, Repair and Replacement of Teeth 3D Systems (NYSE: DDD) today announced it has received full-scope certification under the European Union Medical Device Regulation (EU MDR) 2017/745. The certification was attained on Monday, March 16, 2026. This milestone confirms that the Company’s quality system, technical documentation, and clinical evidence meet the most rigorous regulatory requirements in the medical device sector. With the MDR certificate in hand, 3D Systems will now introduce MDR-compliant product versions through a carefully coordinated, phased rollout across its dental product families and European markets. This approach ensures a smooth transition while maintaining uninterrupted product availability for customers and healthcare providers. The EU MDR certification immediately enables the introduction of innovative new materials and is a pivotal step for one of 3D Syst
Visa to Bring Privacy-Preserving Payments to Canton Network25.3.2026 17:00:00 CET | Press release
Visa is the first payments company selected to become a Super Validator on the Canton Network, where it will help banks and financial institutions bring new payment flows onchain Visa (NYSE:V), a global leader in digital payments, today announced it will join the Canton Network as the first major global payments company to serve as a Super Validator, to help extend privacy‑preserving blockchain infrastructure to banks and financial institutions around the world. Visa will be one of 40 Super Validators on Canton. That move goes straight to a core challenge for financial institutions: the same transparency that gives blockchains their appeal can clash with privacy expectations financial institutions operate under. Canton Network, a blockchain built for regulated finance, has privacy built in from the beginning, so organizations can use shared infrastructure without exposing sensitive information. As a Super Validator, Visa will help clients who choose to run and secure operations on the
ECU Worldwide Unveils XLERATE 2.0 Expansion to Bypass Asia–Europe Supply Chain Disruptions25.3.2026 14:30:00 CET | Press release
Strategic LAX gateway enables faster, predictable cargo movement through a reimagined sea–air logistics model ECU Worldwide, Allcargo Globals’ wholly-owned global subsidiary, has announced a strategic expansion of its transformative logistics solution, XLERATE 2.0, to provide a high-speed and resilient alternative to Asia-to-Europe trade lanes facing transit disruptions. Under this alternative routing, cargo is transported across the Pacific to the US West Coast, using Los Angeles (LAX) as a temporary hub. The solution leverages XLERATE 2.0’s premium, time-definite ocean services, ensuring greater transit agility and continuity. XLERATE 2.0 offers two distinct shipping solutions from China and Vietnam, providing shippers with flexibility as traditional trade arteries remain impacted by shifts in global logistics. These changes have led to reduced overall capacity and the disruption of standard sea–air services via conventional transit points. Commenting on the rollout, Simon Bajada, Re
Incyte Announces Executive Leadership Appointments25.3.2026 14:00:00 CET | Press release
Incyte (NASDAQ:INCY) today announced appointments among its executive leadership team to support the Company’s strategic focus and long-term growth plans. Pablo J. Cagnoni, M.D., has been appointed President, Incyte and Global Head of Research and Development. In this role, Dr. Cagnoni will retain responsibility for Research and Development, while also supporting enterprise-wide strategic planning and operational execution. Under Dr. Cagnoni’s scientific leadership, Incyte’s R&D progress has been notable, including advancing our mutCALR antibody, povorcitinib, CDK2, KRASG12D and TGFßR2xPD1 programs. Dr. Cagnoni has also continued to strengthen the way Incyte conducts R&D, introducing a new structure, processes and new technologies to improve productivity and keep Incyte competitive. Steven Stein, M.D., has been appointed Executive Vice President, Chief Medical Officer and Head of Late-stage Development. In this role, Dr. Stein will continue to oversee Incyte’s extensive and growing lat
Andersen Consulting indgår en samarbejdsaftale med Ventum Consulting25.3.2026 13:58:00 CET | Pressemeddelelse
Andersen Consulting udvider sin globale platform med tilføjelsen af samarbejdspartneren Ventum Consulting, der er et forretnings- og teknologikonsulenthus med base i Tyskland, der specialiserer sig i digital transformation, enterprise agility, produktudvikling, datadrevet innovation samt nye teknologier såsom AI. Ventum Consulting hjælper organisationer med at bygge bro mellem forretning og teknologi ved at levere skræddersyede løsninger inden for strategi, procesoptimering og implementering af it-løsninger. Virksomhedens ekspertise omfatter data og AI, cybersikkerhed, enterprise architecture, bæredygtighed, cloud-transformation samt agile enablement, hvilket kun er et udsnit af deres omfattende serviceportefølje. Ventum Consulting arbejder med kunder på tværs af brancher, herunder bilindustri og produktion, finansielle tjenester og forsikring, sundhedssektoren og life science-industrien samt den offentlige sektor, for at accelerere digital transformation, styrke driftsmæssig robusthed
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