Business Wire

VFMCRP announces approval for TAVNEOS ® (avacopan) for the treatment of ANCA-associated vasculitis in Japan

Share

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 autoimmunediseases 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)).

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

Contact information

Media Relations
Nathalie Ponnier
Global Head Corporate Communications
+41 79 957 96 73
media@viforpharma.com

Investor Relations
Julien Vignot
Head of Investor Relations
+41 58 851 66 90
investors@viforpharma.com

About Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.com

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

NIKE, Inc. Board of Directors Announces Long-Time Nike Veteran Elliott Hill to Return as President and Chief Executive Officer John Donahoe to Retire from Nike19.9.2024 22:15:00 CEST | Press release

The Board of Directors of NIKE, Inc. (NYSE:NKE) announced today that Elliott Hill will become President and Chief Executive Officer of NIKE, Inc., effective October 14, 2024. Hill will also become a Director of the NIKE, Inc. Board of Directors and a member of the Executive Committee. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240919388699/en/ Incoming NIKE, Inc. President & CEO Elliott Hill (Photo: Business Wire) “I am excited to welcome Elliott back to NIKE. Given our needs for the future, the past performance of the business, and after conducting a thoughtful succession process, the Board concluded it was clear Elliott’s global expertise, leadership style, and deep understanding of our industry and partners, paired with his passion for sport, our brands, products, consumers, athletes, and employees, make him the right person to lead Nike’s next stage of growth,” said Mark Parker, Executive Chairman of NIKE, Inc. “Pers

Mary Kay Expands Into Kyrgyzstan, Further Elevating Beauty and Empowerment Around the World19.9.2024 19:03:00 CEST | Press release

Mary Kay Inc., a global leader in skin care and cosmetics, is proud to announce its expansion into Kyrgyzstan, marking a significant milestone in its ongoing international growth strategy. This exciting development underscores Mary Kay’s commitment to empowering women and providing innovative, high-quality skincare and beauty products across the globe. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240919159057/en/ Mary Kay’s expansion into Kyrgyzstan marks another step forward in the company’s mission to enrich women’s lives around the world, offering top-tier beauty products and unparalleled business opportunities. (Photo: Mary Kay Inc.) The beauty and personal care market is experiencing robust growth internationally, with sales volume in these categories almost doubling over the past several years. The beauty market is expected to reach approximately $580 billion by 2027, growing by a projected 6 percent per year1 while

Xsolla Partners With AbleGamers for Charity Campaign at TwitchCon 202419.9.2024 19:00:00 CEST | Press release

Xsolla, a global video game commerce company, is excited to announce its collaboration with AbleGamers for an impactful charity campaign at TwitchCon 2024. This partnership aims to further AbleGamers' mission of improving accessibility in gaming for individuals with disabilities through an interactive and meaningful activation. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240919722398/en/ (Graphic: Xsolla) Attendees who visit the Xsolla booth (Booth 1515-SW) at TwitchCon will have the exclusive opportunity to claim one of two specially designed charity pins. By sharing a photo of their pin on their social channels on Instagram, Facebook, or Twitter using the hashtags #LightstreamAble and #XsollaAble, participants will help raise funds for AbleGamers. For every qualifying social post, Xsolla and its partners will donate $5 to AbleGamers, up to $10,000. To amplify awareness, include hashtags: #TwitchCon #BongoCat #Lightstrea

Sandvine Announces New Ownership and Capital Infusion19.9.2024 18:38:00 CEST | Press release

Sandvine (the “Company”), a market-leading provider of Over-the-Top (OTT) Application Classification and Quality of Experience (QoE) solutions, today announced that it has been acquired by a group of leading US investment firms that previously were, and continue to be, lenders to the Company. In connection with this change of control transaction, the lenders agreed to reduce the Company’s total outstanding debt significantly. Following the change of control transaction, on September 13, 2024, these investors also entered into a binding agreement to provide new capital to Sandvine. The financing is expected to close in September 2024 and will strengthen the Company’s balance sheet. These enhancements to Sandvine’s financial position accompany its recently announced reorientation of its business model to focus on serving customers in large democratic markets. Together, these developments enable the Company to continue serving as the technology partner of choice for scaled, sophisticated

Neuraptive Therapeutics Announces Presentation of Phase 2 Topline Interim Results for NTX-001 at the 2024 American Society for Surgery of the Hand (ASSH) Annual Meeting19.9.2024 18:31:00 CEST | Press release

Neuraptive Therapeutics Inc., a leading biopharmaceutical company focused on novel treatments for peripheral nerve injuries, today announced that interim topline results from its ongoing Phase 2 NEUROFUSE Study will be presented at the 2024 American Society for Surgery of the Hand (ASSH) Annual Meeting, held September 19-21 in Minneapolis, MN. The presentation, titled Safety and Efficacy of NTX-001 in the Treatment of Acute Single Transected Peripheral Nerve Injuries: A Phase 2 Randomized Controlled Trial, was awarded a Top 10 Best Paper designation and will be presented by Dr. David Brogan of Washington University during the scientific paper session on Thursday, September 19. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240919597699/en/ David M. Brogan, MD, MSc, Assistant Professor, Orthopaedic Surgery, Division of Hand and Microsurgery, Washington University in St. Louis (Photo: Business Wire) The presentation will highl

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
HiddenA line styled icon from Orion Icon Library.Eye