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Roxadustat Approved in Japan for the Treatment of Anemia Associated with Chronic Kidney Disease in Dialysis PatientsSAN FRANCISCO and TOKYO, Sept. 20, 2019 (GLOBE NEWSWIRE) -- FibroGen, Inc. (Nasdaq: FGEN, Interim CEO: James A. Schoeneck, “FibroGen”) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) approved Evrenzo® (generic name: roxadustat; tradename Evrenzo® in Japan) for the treatment of anemia associated with chronic kidney disease (CKD) in dialysis patients. Roxadustat is a first-in-class orally administered inhibitor of hypoxia-inducible factor (HIF) prolylhydroxylase that corrects anemia by a mechanism of action that is different from that of erythropoiesis-stimulating agents (ESAs). As a HIF-PH inhibitor, roxadustat activates a response that occurs naturally when the body responds to reduced oxygen levels in the blood. The response activated by roxadustat involves the regulation of multiple, complementary processes to promote erythropoiesis and increase the blood’s oxygen-carrying capacity. "Evrenzo® is a valuable new treatment option for dialysis patients with CKD anemia,” said Bernhardt G. Zeiher, M.D., Chief Medical Officer, Astellas. “Astellas is committed to improving the health of people worldwide and expanding treatment options, especially within the dialysis community where there is high-unmet need. We are delighted to bring this important new treatment option to both patients suffering from, and healthcare professionals treating, this debilitating condition.” CKD anemia can severely worsen the outcomes of kidney disease, increasing the rate of progression to renal failure1 and the likelihood of cardiovascular complications.2 It also significantly reduces patients’ quality of life and their cognitive ability.3 Reaching and maintaining target hemoglobin levels can present challenges and roxadustat provides an alternative therapeutic option. “We appreciate the commitment and focus of our partner Astellas as we work together to bring a new therapy to CKD anemia patients on dialysis in Japan,” said K. Peony Yu, M.D., Chief Medical Officer, FibroGen. “With this approval in Japan, NDA approval in China, and EU MAA and U.S. NDA preparations underway, we are another step closer to our goal of addressing the significant unmet medical need of patients living with anemia associated with CKD, worldwide.” The approval is based on four Phase 3 studies conducted in CKD anemia patients on dialysis in Japan.4,5,6,7 The studies demonstrated that roxadustat was effective at raising hemoglobin and that it was well-tolerated. This marks the first approval for roxadustat through the Astellas and FibroGen collaboration. Product Information
About Chronic Kidney Disease (CKD) and Anemia Anemia is a common early complication of CKD,11 affecting approximately 20% f patients with CKD.12 It results from the failing kidneys’ diminished ability to produce erythropoietin that stimulates red blood cell production from the bone marrow, and is associated with significant morbidity and mortality in dialysis and non-dialysis populations, increasing in both prevalence and severity as kidney disease worsens.13 CKD anemia increases the risk of adverse cardiovascular events, worsens renal outcomes and negatively impacts patients’ quality of life.14,15 In addition, CKD can be both a cause and a consequence of cardiovascular disease and is now a critical worldwide healthcare issue that represents a large and growing unmet medical need. About Roxadustat Astellas and FibroGen are collaborating on the development of roxadustat for the potential treatment of anemia in territories including Japan, Europe, the Commonwealth of Independent States, the Middle East, and South Africa. FibroGen and AstraZeneca are collaborating on the development and commercialization of roxadustat for the potential treatment of anemia in the U.S., China, and other markets. About FibroGen About Astellas FibroGen Forward-looking Statements Astellas Cautionary Notes Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice. Contacts for inquiries or additional information: Karen L. Bergman Astellas Pharma Inc. References: 1 Mohanram A, Zhang Z, Shahinfar S,ET AL. Anemia and end-stage renal disease in patients with type 2 diabetes and nephropathy. Kidney Int. 2004 Sep;66(3):1131-8. 2 Weiner DE , Tighiouart H, Stark PC et al. Kidney disease as a risk factor for recurrent cardiovascular disease and mortality. Am J Kidney Dis. 2004 Aug;44(2):198-206. 3 Eriksson D et al. Cross-sectional survey in CKD patients across Europe describing the association between quality of life and anaemia. BMC Nephrology. 2016;17:97. 4 1517-CL-0302: Announced on a press release issued on October 31, 2017. Available at: https://www.astellas.com/jp/en/news?type=date&tab=date&year=2017&month=10 5 1517-CL-0308: Announced on slide no. 29 of presentation material at Astellas FY2017 business announcement on April 26, 2018. Available at: https://sw4503.swcms.net/en/ir-library/business-results/inframe/main/00/teaserItems1/00/linkList/02/link/4q2018_pre_en.pdf 6 1517-CL-0312: Announced on slide no. 29 of presentation material at Astellas FY2017 business announcement on April 26, 2018. Available at: https://sw4503.swcms.net/en/ir-library/business-results/inframe/main/00/teaserItems1/00/linkList/02/link/4q2018_pre_en.pdf 7 1517-CL-0307: Announced on a press release issued on May 31. Available at: https://www.astellas.com/jp/en/news/11951 8 Ojo, A. Addressing the Global Burden of Chronic Kidney Disease Through Clinical and Translational Research. Transactions of the American Clinical and Climatological Association. 2014, No. 125, p. 229-246. 9 The Global Kidney Health Atlas. International Society of Nephrology (ISN). Available at: https://www.kidneycareuk.org/news-and-campaigns/news/estimated-1-10-people-worldwide-have-chronic-kidney-disease/. Last accessed August 2019. 10 Nagata M, Ninomiya T, Doi Y, Yonemoto K, Kubo M, Hata J, Tsuruya K, Iida M, Kiyohara Y. Nephrol Dial Transplant. 2010, Aug, vol. 25, no.8, 2557-2564. 11 McClellan W, Aronoff SL, Bolton WK, et al. The prevalence of anemia in patients with chronic kidney disease. Curr.Med.Res.Opin. 2004;20:1501–1510. 12 Dmitrieva O, De Lusignan S, Macdougall, IC, et al. Association of anaemia in primary care patients with chronic kidney disease: cross sectional study of quality improvement in chronic kidney disease (QICKD) trial data. BMC Nephrology. 2013:25;14:24. 13 KDOQINational Kidney Foundation: KDOQI Clinical Practice Guidelines and Clinical Practice Recommendations for Anemia in Chronic Kidney Disease. Am J Kidney Dis 47 [Suppl 3]: S11–S145, 2006. 14 Eriksson D et al. Cross-sectional survey in CKD patients across Europe describing the association between quality of life and anaemia. BMC Nephrology. 2016;17:97. 15 KDOQINational Kidney Foundation: KDOQI Clinical Practice Guidelines and Clinical Practice Recommendations for Anemia in Chronic Kidney Disease. Am J Kidney Dis 47 [Suppl 3]: S11–S145, 2006. |