VFMCRP and ChemoCentryx announce European Medicines Agency has accepted to review the Marketing Authorization Application for avacopan
3.11.2020 09:00:00 EET | Business Wire | Press release
Regulatory News:
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201102005955/en/
Vifor Fresenius Medical Care Renal Pharma (VFMCRP) Ltd. and ChemoCentryx, Inc., today announced that the 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 polyangitis (GPA) and microscopic polyangiitis (MPA)), a group of rare and severe autoimmune diseases with high need for targeted therapies.
If approved, avacopan would be the first orally administered selective complement 5a receptor inhibitor, for the treatment of patients with anti-neutrophil cytoplasmic antibody-associated vasculitis. Data from the global pivotal phase-III ADVOCATE trial demonstrated statistical superiority in sustaining remission at 52 weeks in the avacopan group compared to the prednisone group. In the trial, the avacopan group also showed significantly lower glucocorticoid toxicity, greater improvement in kidney function and greater improvement in health-related quality of life measures compared to the prednisone group.
The EMA will review the application under the centralized marketing authorization procedure. If approved avacopan would receive marketing authorization in all member states of the European Union (EU), as well as in Iceland, Liechtenstein and Norway. Approval is expected H2, 2021.
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 ChemoCentryx
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. ChemoCentryx’s lead drug candidate, avacopan (CCX168), successfully completed a pivotal Phase III trial in ANCA-associated vasculitis.
ChemoCentryx also has early stage drug candidates that target chemoattractant receptors in other inflammatory and autoimmune diseases and in cancer.
About ADVOCATE and ANCA-Associated Vasculitis
The ADVOCATE trial of avacopan was a global double-blind double-dummied Phase III trial of 331 patients with ANCA-associated vasculitis (ANCA vasculitis) in 20 countries.
ANCA 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 a major target. Treatment for ANCA vasculitis consists of courses of immuno-suppressants (cyclophosphamide or rituximab), combined with high-dose and often prolonged use of glucocorticoids which can be associated with significant adverse events. ANCA vasculitis is relapsing and remitting long term condition and patients are at risk of cumulative organ damage.
About 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 ANCA vasculitis. Avacopan therapy was designed to deliver effective control of the inflammatory vasculitic process and prevent relapse while also reducing the risk of treatment related damage. 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.
Forward-Looking Statements
ChemoCentryx cautions that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as "may," "could," "will," "would," "should," "expect," "plan," "anticipate," "believe," "estimate," "intend," "predict," "seek," "contemplate," "potential," "continue" or "project" or the negative of these terms or other comparable terminology are intended to identify forward-looking statements. These statements include the Company's statements regarding whether avacopan will be approved for the treatment of ANCA vasculitis. The inclusion of forward-looking statements should not be regarded as a representation by ChemoCentryx that any of its plans will be achieved. Actual results may differ from those set forth in this release due to the risks and uncertainties inherent in the ChemoCentryx business and other risks described in the Company's filings with the Securities and Exchange Commission ("SEC"). Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and ChemoCentryx undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. Further information regarding these and other risks is included under the heading "Risk Factors" in ChemoCentryx's periodic reports filed with the SEC, including ChemoCentryx's Annual Report on Form 10-K filed with the SEC on March 10, 2020 and its other reports which are available from the SEC's website (www.sec.gov) and on ChemoCentryx's website (www.chemocentryx.com) under the heading "Investors." All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20201102005955/en/
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
ChemoCentryx Contacts:
Susan M. Kanaya
Executive Vice President
Chief Financial and Administrative Officer
investor@chemocentryx.com
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
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
Icon Solutions Showcases How Banks Can Accelerate Digital Asset Innovation with IPF9.6.2026 12:30:00 EEST | Press release
Icon Solutions – the UK fintech enabling banks to design and implement state-of-the-art payment systems – has released a reference implementation showing how banks can use the Icon Payments Framework (IPF) to accelerate support for payments processing using distributed ledger technology (DLT)-based digital assets. As IPF is agnostic to both the type of digital asset and the DLT network on which they are issued, the risk of fragmentation is reduced as adoption scales. There is growing momentum for digital assets such as stablecoins, tokenised deposits, deposit tokens and central bank digital currencies (CBDCs) to enable faster, cheaper and smarter payments. Yet the emergence of different digital asset types and DLT networks – which must also work with existing financial infrastructure – creates fragmentation and operational complexity for banks. This is compounded by legacy vendor solutions that limit choice and lock banks in, making it slow, costly and risky to make the changes require
monday.com Appoints Ben Barnett General Manager of EMEA to Drive Next Phase of Regional Growth9.6.2026 11:00:00 EEST | Press release
monday.com (Nasdaq: MNDY), the AI work platform that turns strategy into execution at scale, today announced Ben Barnett’s appointment to General Manager (GM) of Europe, the Middle East and Africa, marking a major milestone in the company’s global expansion. Ben, who has been with monday.com for five years, brings a decade of experience in senior B2B sales roles at software companies and has overseen significant, sustained growth at monday.com in the UK and Ireland since joining in 2021. In his new position, Ben’s priorities include delivering the monday.com’s EMEA go-to-market strategy, fostering key partnerships, and bolstering its newly announced AI work platform. He is based in London. Ben’s promotion comes as monday.com builds on a period of rapid regional success, with EMEA revenue up 26% year-on-year in 2025. Last year, monday.com expanded its regional EMEA headquarters in Fitzrovia, London, now occupying 80,000 sq ft across three floors where more than 370 employees are based,
Interactive Brokers Launches Commission-Free iShares ETFs from BlackRock through Recurring Investment Feature Across Europe9.6.2026 11:00:00 EEST | Press release
Interactive Brokers (Nasdaq: IBKR), an automated global broker, today announced the launch of Commission-Free ETFs within its Recurring Investment feature for eligible individual investors across the European Economic Area. Investors can now access more than 500 commission-free iShares ETFs from BlackRock spanning a broad range of asset classes and strategies, including bonds, equities, themes and sectors. The iShares ETFs available on the IBKR platform give individual investors an accessible, cost-efficient way to build well-diversified portfolios. Since investors pay no trading commissions, more of their capital stays invested and compounding over time, while a broad selection of funds across asset classes makes it straightforward to construct and rebalance portfolios. iShares ETFs are available commission-free through IBKR's Recurring Investments feature, allowing investors to automate their periodic ETF contributions. Clients can select individual ETFs or ETF portfolios, set a cont
Forrester Reveals The Top 10 Highest-Performing Brands In Its 2026 Global Total Experience Score Rankings At Its CX Events9.6.2026 10:30:00 EEST | Press release
According to Forrester’s (Nasdaq: FORR) 2026 global Total Experience Score rankings of 375 brands evaluated across Asia Pacific, Europe, and North America in 2025 and 2026, 41% improved their scores while only 3% declined. A compelling total experience — calculated by combining Forrester’s Customer Experience Index (CX Index™), Brand Experience Index (BX Index™), and, for the first time, the new Employee Experience Index (EX Index™) into a unified view of performance — can drive outsized growth for brands. While brand experience and customer experience can each drive revenue independently, the impact multiplies when they are orchestrated together as a unified total experience. In the US, for example, companies delivering a strong total experience see significantly higher returns from retention and enrichment: Automotive firms achieve a 2.6x revenue lift and retailers see a 3.8x increase. The new research finds that CX scores improved in North America, European brands remained mostly st
IQM Announces Novel Quantum Error Correction Approach Toward Fault-Tolerant Quantum Computing9.6.2026 10:00:00 EEST | Press release
IQM Quantum Computers, the global leader in superconducting quantum computers, has developed a novel quantum error-correcting code that achieves up to three orders of magnitude lower logical error rates than the surface code, also requiring up to eight times fewer physical qubits. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260609533201/en/ IQM´s breakthrough technology, called barbell codes. Unlike many alternative high-performance quantum error-correction approaches, the new code also maintains a comparatively low hardware complexity, marking a significant advancement toward scalable fault-tolerant quantum computing. Quantum error correction remains one of the defining challenges in the race toward practical quantum computing. Errors introduced by noise must be corrected faster than they accumulate, a requirement that previous approaches demanded either complex hardware or significant performance trade-offs, which IQM's
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