Therapy Areas: Cardiovascular
VFMCRP Approves Tavneos for the Treatment of ANCA-Associated Vasculitis in Japan
27 September 2021 - - Japan's Ministry of Health and Labor Welfare has granted its partner, Kissei Pharmaceutical Co., Ltd., marketing authorization approval for Tavneos for the treatment of patients with granulomatosis with polyangiitis and microscopic polyangiitis, the two main types of ANCA-associated vasculitis, Switzerland-based pharmaceuticals company Vifor Fresenius Medical Care Renal Pharma said.

ANCA-associated vasculitis is a rare and severe autoimmune renal disease with high unmet medical need.

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.

VFMCRP holds the rights to commercialize Tavneos outside the US. 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 US Food and Drug Administration and the European Medicines Agency.

Vifor Pharma Group is a global pharmaceuticals company. It aims to become a leader in iron deficiency, nephrology and cardio-renal therapies.

The company develops, manufactures and markets pharmaceutical products for precision patient care. Vifor Pharma Group holds positions in 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).

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 and D-oriented corporation.

Kissei is engaged in R and 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.
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