ST. GALLEN, Switzerland – (COMMERCIAL THREAD) – Vifor Fresenius Medical Care Renal Pharma (VFMCRP) today announced that the Japanese Ministry of Health and Labor (MHLW) has granted its partner, Kissei Pharmaceutical Co., Ltd., the marketing authorization the market for TAVNEOS® for the treatment of patients with granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA), the two main types of vasculitis associated with ANCA, a rare and severe autoimmune kidney disease with high unmet medical need.
“We are delighted that TAVNEOS® has been approved in Japan, the world’s largest market, and congratulate our partner Kissei on this important milestone, ”said Abbas Hussain, CEO of Vifor Pharma Group. “ANCA-associated vasculitis is officially designated as an incurable disease in Japan, indicating a rare disease without any effective treatment but for which long-term treatment is required. There are significant unmet medical needs of over 10,000 patients in Japan, and we believe in the potential of TAVNEOS® to process it. We are confident that Kissei will fully focus on bringing this revolutionary treatment to this patient population, helping them lead better and healthier lives. ”
The approval is based on the filing of the Marketing Authorization Application by Kissei, which was supported by positive clinical data from the pivotal phase III ADVOCATE trial in a total of 331 patients with MPA and surgeries in 18 countries and regions, including Japan. TAVNEOS® demonstrated superiority over standard care at week 52 based on the Birmingham Vasculitis Activity Score (BVAS).
VFMCRP holds the marketing rights for TAVNEOS® Outside the United States. In June 2017, VFMCRP granted Kissei the exclusive right to develop and market TAVNEOS® in Japan. Kissei plans to start marketing TAVNEOS® as soon as possible after the NHI price list. Outside of Japan, TAVNEOS is currently under regulatory review with various agencies, including the United States Food and Drug Administration and the European Medicines Agency.
About the Vifor Pharma Group
The Vifor Pharma Group is a global pharmaceutical company. It aims to become the world leader in iron deficiency, nephrology and cardio-renal therapies. The company is a partner of choice for pharmaceuticals and innovative patient-centric solutions. The Vifor Pharma Group strives to help patients around the world with severe and chronic illnesses lead better and healthier lives. The company develops, manufactures and markets pharmaceutical products for precision patient care. The Vifor Pharma Group occupies a leading position in all its main activities and consists of the following companies: Vifor Pharma and Vifor Fresenius Medical Care Renal Pharma (a joint company with Fresenius Medical Care). The 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 viveorpharma.com.
About Kissei Pharmaceutical Co., Ltd.
Kissei Pharmaceutical Co., Ltd. is a Japanese pharmaceutical company with around 70 years of history. Based on its management philosophy, “contributing to society through innovative high quality pharmaceutical products” and “serving society through our employees”, Kissei focuses on providing innovative pharmaceutical products to patients all over the world. as a company with a strong R&D focus. Kissei is engaged in R&D and licensing activities in the field of nephrology / dialysis, urology and unmet medical needs in other pathological fields. Kissei established a collaboration with VFMCRP for sucroferric oxyhydroxide which Kissei developed entirely in Japan under the name P-TOL® (known as Velphoro® in Europe / United States) for the treatment of hyperphosphatemia. Since the launch in 2015, the market share of P-TOL® is constantly 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 drugs for inflammatory and autoimmune diseases and cancer. ChemoCentryx targets chemokine and chemotactic systems to discover, develop and commercialize orally administered therapies. In addition to ChemoCentryx’s primary drug candidate, avacopan, ChemoCentryx also has early-stage drug candidates that target chemoattractant receptors in other inflammatory and autoimmune diseases. diseases and in cancer.
About vasculitis associated with ANCAs
ANCA-associated vasculitis is a systemic disease in which overactivation of the complement pathway further activates neutrophils, leading to inflammation and destruction of small blood vessels. This leads to organ damage and failure, with the kidney being the primary target, and is fatal if left untreated. Currently, treatment of ANCA-associated vasculitis consists of courses of non-specific immunosuppressants (cyclophosphamide or rituximab), combined with daily administration of glucocorticoids (steroids) for prolonged periods, which may be associated with significant clinical risk. up to death. of infection.
About TAVNEOS® (avacopane)
Avacopan is an orally administered small molecule that is a selective inhibitor of the complement C5aR1 receptor. By precisely blocking the receptor (C5aR) of the pro-inflammatory complement system fragment, C5a on destructive inflammatory cells such as blood neutrophils, avacopan stops the ability of these cells to damage in response to activation of C5a , which is known to be the engine of inflammation. In addition, avacopan’s selective inhibition of C5aR1 alone leaves the beneficial C5a1 pathway through the C5L2 receptor to function normally.
ChemoCentryx is also developing avacopan for the treatment of patients with C3 glomerulopathy (C3G) and hidradenitis suppurativa (HS). The United States Food and Drug Administration has granted orphan drug designation avacopan for ANCA-associated vasculitis, C3G, and atypical hemolytic uremic syndrome. The European Commission has granted orphan drug designation to 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, the European Medicines Agency (EMA) agreed to review the Marketing Authorization Application (MAA) of avacopan for the treatment of patients with ANCA-associated vasculitis (granulomatosis with polyangiitis ( GPA) and microscopic polyangiitis (MPA)).