Business Wire India
- Companies have completed EU regulatory application for marketing approval of Avacopan
- Regulatory deposits based on positive data from the pivotal Phase-III ADVOCATE trial of Avacopan
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Vifor Fresenius Medical Care Renal Pharma (VFMCRP) Ltd. And ChemoCentryx, Inc., announced today that the European Medicine Agency (EMA) accepts reviewing the Marketing Authorization Application (MAA) for Avacasan for the treatment of patients with vasculitis () associated with ANCA. Granulomatosis, with polyangitis (GPA) and microscopic polyangitis (MPA), is a group of rare and severe autoimmune diseases with a high need for targeted therapy.
If approved, avacopan will be an orally administered selective complement 5A receptor inhibitor for the treatment of patients with vasculitis associated with anti-neutrophil cytoplasmic antibodies. Data from the global decisive phase-III ADVOCATE trial demonstrated statistical superiority in maintaining avidity at 52 weeks in the avacopan group compared to the prednisone group. In the trial, the avacopain group also showed significantly lower glucocorticoid toxicity, greater improvement in renal function and greater quality of life compared to the prednisone group.
The EMA will review the application under the centralized marketing authorization process. If approved Avacopan will receive marketing authorization in all member states of the European Union (EU), as well as Iceland, Liechtenstein and Norway. Approval is H2, 2021.
Vifor Pharma Group Is a global pharmaceuticals company. It aims to become a global leader in iron deficiency, nephrology and cardio-renal therapy. The company is the partner of choice for pharmaceuticals and innovative patient-centric solutions. Vifor Pharma Group strives to help patients around the world with serious and chronic diseases that improve health. The company develops, manufactures and markets pharmaceutical products for precise patient care. Vifor Pharma Group occupies a leading position in all its core business activities and includes 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 is listed on the Swiss Stock Exchange (SIX Swiss Exchange, VIFN, ISIN: CH0364749348).
for more information please visit viforpharma.com
ChemoCentryx is a biopharmaceutical company developing new drugs for inflammatory and autoimmune diseases and cancer. ChemoCentryx targets the chemokine and chemoattract systems to discover, develop, and commercialize orally administered therapies. ChemoCentryx’s flagship drug candidate, Avacopan (CCX168), successfully completed a decisive phase III trial in ANCA-associated vasculitis.
Chemocytrix also contains early-stage drug candidates that target chemoattractant receptors in other inflammatory and autoimmune diseases and cancers.
About ADVOCATE and ANCA-Associated Vasculitis
The ADVOCATE trial of avakopan was a global double-dandel double-dummied phase III trial of 331 patients with ANCA-associated vasculitis in 20 countries.
ANCA vasculitis is a systemic disease in which greater activation of the complement pathway further activates neutrophils, leading to inflammation and destruction of small blood vessels. It is the result of organ damage and failure, with the kidney as a major target. Treatment for ANCA vasculitis includes courses of immuno-suppressants (cyclophosphamide or retuximab), combined with high doses and often prolonged use of glucocorticoids that may be associated with significant adverse events. ANCA vasculitis is relapsing and transmitting the long-term condition and patients are at risk of cumulative organ damage.
Avacopan is an orally administered small molecule that is a selective inhibitor of the complement C5a receptor C5aR1. By properly blocking the receptor (C5aR) for fragments of the pro-inflammatory complement system, C5a on destructive inflammatory cells, such as blood neutrophils, arrests the ability of those cells known to do damage in response to Avacopan C5a activation. Goes the driver of ANCA vasculitis. Avacopan therapy was designed to deliver effective control of the inflammatory vasculitic process and prevent relapse while reducing the risk of treatment-related damage. In addition, selective inhibition of avacopan only to C5aR1 normally bypasses the beneficial C5a L pathway via C5L2 receptor functioning.
ChemoCentryx is also developing avacopan for the treatment of patients with co glomerulopathy (C3G) and hidradenitis suppurativa (HS). The US Food and Drug Administration has granted Avacopan orphan-drug designation for ANCA-associated vasculitis, C3G, and atypical hemolytic uremic syndrome. The European Commission has designated orphan medicinal product designation for avacopan for the treatment of two forms of ANACA vasculitis: microscopic polyangitis and granulomatosis polyangitis (formerly known as Vegan’s granulomatosis) as well as for C3G. .
In the statements included in this press release, Chamocentriks warns that historical facts do not detail. “May,” “,” may, “” shall, “” should, “” should, “” plan, “” anticipate, “” believe, “” anticipate, “” intend, “” predict, ” Identifying “forward-looking,” “contemplation,” “potential,” “ongoing” or “project” or negative forward-looking statements of these terms or other comparable terminology. These statements include company statements that remedies for ANACA vasculitis Whether or not Avakopan will be approved for the inclusion of forward-looking statements should not be construed as representing by ChemoCentryx that any of its plans will be achieved. Actual results may differ from those in this release, Which are other risks described in the Chemohertrix business due to inherent risks and uncertainties and 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. Speak only on that date, and Chemocentrics bears no obligation to modify or update the news that events or events after the date Reflect the conditions. Further information about these and other risks has been filed with the SEC under the heading “Risk Factors” filed with the SEC on Form 10-K filed with the SEC on March 10, 2020. The annual report of and its other reports are available. From the SEC website (www.sec.gov) And on Chemoventrix’s website (www.chemocentryx.com) Under the heading “Investor.” All careful-looking statements are qualified by this caution statement in their entirety. This precaution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.
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