VIFOR
Vifor Fresenius Medical Care Renal Pharma (VFMCRP) is pleased to announce that England’s National Institute for Health and Care Excellence (NICE) has recommended Tavneos® in combination with a rituximab or cyclophosphamide regimen for the treatment of adult patients with severe, active granulomatosis polyangiitis (GPA) or microscopic polyangiitis (MPA), two main forms of AAV. The decision follows authorization from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) in May 2022.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220817005538/en/
“ANCA-associated vasculitis is a rare, systemic disease which can be rapidly fatal if not appropriately & promptly treated. The variable nature of the disease and its course along with challenging side-effects of current treatment options can severely affect subsequent quality of life for patients,” said John Mills, Vice-Chair of Vasculitis UK. “We very much welcome NICE’s decision, which means that eligible patients and clinicians have another choice of treatment for this debilitating condition.”
“NICE’s decision represents a major advancement for the treatment of GPA/MPA in the UK,” said Prof. David Jayne, Professor of Clinical Autoimmunity, University of Cambridge. “Patients will now have access to a new therapy option that could help them optimize their treatment outcomes.”
“We are delighted about this recommendation for patients in England, Wales and Northern Ireland living with GPA/MPA”, said Dr. Klaus Henning Jensen, Chief Medical Officer of CSL Vifor. “It means that an underserved patient population will have access to a first in class treatment aiming to meet major unmet medical needs. We look forward to continue working with the National Health Service to ensure access to this important medicine for patients across the UK as quickly as possible.”
MHRA approval and the NICE recommendation were based on findings from a comprehensive development program, culminating in the results from the pivotal phase-III trial (ADVOCATE) in 331 patients with ANCA-associated vasculitis (GPA/MPA) in 20 countries. This randomized, controlled trial assigned patients to either oral Tavneos® (30mg twice daily) or oral prednisolone on a tapering schedule. All patients received induction treatment with cyclophosphamide or rituximab. The study met its primary endpoints of disease remission at week 26, defined as Birmingham Vasculitis Activity Score (BVAS) of 0 at week 26 and not taking glucocorticoids for treatment of ANCA-associated vasculitis in the previous 4 weeks, and sustained remission at both weeks 26 and 52 defined as a BVAS of 0 and not taking glucocorticoids for treatment of ANCA-associated vasculitis within 4 weeks prior to week 52. Compared to a prednisolone-based regimen, the Tavneos® -based regimen demonstrated non-inferiority in terms of remission at week 26, and superiority in terms of sustained remission at week 52. Serious adverse events (excluding worsening vasculitis) occurred in 37.3% of patients receiving Tavneos® and in 39% of those receiving prednisolone.
About CSL Vifor
CSL Vifor is a global partner of choice for pharmaceuticals and innovative, leading therapies in iron deficiency, dialysis and nephrology & rare disease. We specialize in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision healthcare, aiming to help patients around the world lead better, healthier lives. Headquartered in St. Gallen, Switzerland, CSL Vifor also includes the joint company Vifor Fresenius Medical Care Renal Pharma (with Fresenius Medical Care). The parent company, CSL (ASX:CSL; USOTC:CSLLY), headquartered in Melbourne, Australia, employs 30,000 people and delivers its lifesaving therapies to people in more than 100 countries. For more information about CSL Vifor visit, www.cslvifor.com
About GPA and MPA
GPA and MPA are the two main forms of ANCA-associated vasculitis which is a systemic disease in which inappropriate 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 and lung as major targets, and may be fatal if not treated.
Treatment of GPA/MPA consists of courses of potent immuno-suppressants, in combination with high-dose glucocorticoids (steroids) for prolonged periods of time. However, the unmet medical need remains high as these patients face significant risk of complications, both from their disease and adverse effects from medications, including from long-term use of glucocorticoids. Treatment goals are to achieve sustainable remission to reduce vascular damage and preserve organ function while minimizing the side effects of current treatments.
About Tavneos® (avacopan)
Tavneos® (avacopan) is an orally administered small molecule that is a selective inhibitor of the complement C5a receptor C5aR1. By blocking this receptor (C5aR1) for the pro-inflammatory complement system fragment, C5a on inflammatory cells such as neutrophils, Tavneos® reduces the ability of those cells to do damage in response to C5a activation. Moreover, Tavneos® selective inhibition of only the C5aR1 is expected to leave the formation of the beneficial C5b-9 complex intact.
Tavneos® was developed by ChemoCentryx, Inc., who is also developing Tavneos® for the treatment of patients with C3 Glomerulopathy (C3G) and hidradenitis suppurativa (HS). The U.S. Food and Drug Administration has granted Tavneos® orphan-drug designation for ANCA-associated vasculitis, C3G and atypical hemolytic uremic syndrome. The European Commission has granted orphan medicinal product designation for Tavneos® for the treatment of two forms of ANCA-associated vasculitis: MPA and GPA (formerly known as Wegener's granulomatosis), as well as for C3G.
VFMCRP has a licensing agreement with ChemoCentryx, Inc., to commercialize Tavneos® outside the US.
# # #
View source version on businesswire.com: https://www.businesswire.com/news/home/20220817005538/en/
Link:
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
Helical Fusion Signs Japan’s First Power Purchase Agreement for Fusion Energy with Aoki Super8.12.2025 10:00:00 CET | Press release
Agreement signals growing market demand for stable, continuous, net-electricity fusion power based on the Helical Stellarator Helical Fusion Co., Ltd. (Headquarters: Tokyo, Japan; “Helical Fusion”), a company developing a commercially viable Helical Stellarator power plant under its “Helix Program”, has signed a Power Purchase Agreement (PPA) with Aoki Super Co., Ltd. (Headquarters: Aichi, Japan; “Aoki Super”), a major regional supermarket chain in central Japan. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251207372064/en/ Takaya Taguchi (left), CEO of Helical Fusion Co., Ltd. , and Masayuki Kono (right) Managing Director and Head of Administration Division of Aoki Super Co., Ltd. at the press conference held on December 8, 2025 This marks the first fusion-energy PPA ever signed in Japan, representing a concrete step forward in the real-world adoption of fusion energy and signaling growing demand-side engagement in the em
Tecnotree Mentioned in Various 2025 Gartner® Research8.12.2025 09:41:00 CET | Press release
Tecnotree is a 5G-ready digital Business Support System (BSS) provider with advanced AI/ML capabilities and multi-cloud extensibility. The company has been listed across thirteen 2025 Gartner research spanning Digital BSS, AI-driven monetization, digital marketplace enablement, and customer experience transformation. We believe these mentions reflects the continued relevance and strong applicability of Tecnotree’s solutions within the technology domains evaluated by Gartner. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251208688494/en/ Tecnotree Mentioned in Various 2025 Gartner® Research The research span Market Guides, Hype Cycles, Magic Quadrants, Critical Capabilities, and Competitive Landscape reports, which we think collectively provides an overview of how various technologies are evolving across the communications ecosystem. We believe that Tecnotree’s appearance across these research categories underscores what we
AI Won't Transform Mobility Without Unprecedented Collaboration, Study Reveals8.12.2025 09:25:00 CET | Press release
First comprehensive analysis of real-world AI applications exposes critical gap between technology's promise and scaled deployment, according to the MIT Mobility Initiative and Kearney Advanced Mobility Institute Artificial intelligence is quietly reshaping global transportation systems, but most deployments remain isolated pilots that haven't achieved scale – and the gap between AI's promise and its execution is widening, according to a landmark study launched today at CoMotion GLOBAL in Riyadh. The Envisioning the Future of Mobility Powered by AI report, developed by the MIT Mobility Initiative and Kearney Advanced Mobility Institute, analyzed input from 55 leading global organizations, including Google, Lyft, Uber Freight, Deutsche Bahn, and NEOM. The study mapped real-world AI applications across mobility systems in Europe, the Americas, APAC, and the Middle East – revealing both breakthrough potential and fundamental challenges in bringing AI-powered mobility to scale. The report
ATEC2025·Real-World Extreme Challenge Concludes with Zhejiang University Team Claiming $150,000 Prize for Breakthrough in Fully Autonomous Robotics8.12.2025 09:25:00 CET | Press release
Thirteen global teams push the boundaries of “no remote control” robotics, driving the evolution from teleoperated tools to autonomous agents The ATEC2025·Real-World Extreme Challenge successfully concluded on December 7 on the campus of The Chinese University of Hong Kong. A team from Zhejiang University emerged victorious from a field of 13 talented international squads by demonstrating exceptional fully autonomous embodied intelligence, securing the top prize of $150,000 USD. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251207877880/en/ A Zhejiang University team wins ATEC2025·Real-World Extreme Challenge Organized by the Chinese University of Hong Kong and co-hosted by Advanced Technology Exploration Community (ATEC), Peking University, Beijing Normal University, and Ant Group, ATEC2025·Real-World Extreme Challenge was the world’s first intelligent robotics challenge held entirely outdoors on natural terrain—featuring
SIAL Paris 2026 : The Entire Food Industry in One Place – An Unmissable Event for Professionals8.12.2025 09:00:00 CET | Press release
SIAL Paris 2026 is more than ever the world’s must-attend food industry event With less than a year to go, SIAL Parisonce again stands as a key international gathering for food industry professionals. With 85% of exhibition space already booked, the show demonstrates very strong momentum and appeal. SIAL Paris will welcome 295,000 professionals from 200 countries across a stunning 280,000 m² of exhibition space, covering all sectors of the food industry. Innovation at the core of global food transformation In a context marked by major demographic, environmental and geopolitical challenges, SIAL Paris stands as THE hub where innovation drives action, business, and transformation. It brings across all sectors’ ideas, projects, and solutions that address today’s challenges, all while inspiring food business around the world. As in every edition, the show will offer a unique immersive experience, facilitating meaningful meetings and business opportunities. SIAL Paris serves as the global i
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