Astellas Receives Approval of EVRENZO® (roxadustat) in Japan for the Treatment of Anemia of Chronic Kidney Disease in Adult Patients Not on Dialysis
SAN FRANCISCO and TOKYO, Nov. 27, 2020 (GLOBE NEWSWIRE) -- FibroGen, Inc. (Nasdaq: FGEN, CEO: Enrique Conterno, “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® (roxadustat) for the treatment of anemia of chronic kidney disease (CKD) in adult patients not on dialysis. This marks the second approval in Japan for roxadustat through the Astellas and FibroGen collaboration, after the therapy was approved and launched for use in adult patients with anemia of CKD on dialysis last year.
“We are delighted roxadustat is now approved in Japan for adults with anemia of CKD not on dialysis, as it allows even more patients to access this important new treatment option,” said Bernhardt G. Zeiher, M.D., Chief Medical Officer, Astellas. “With its novel mechanism of action and oral administration, we hope roxadustat will alleviate some of the burden associated with anemia of CKD prior to the initiation of dialysis and deliver meaningful improvements in the lives of these patients.”
This approval is based on results obtained from three clinical studies in more than 500 Japanese patients with anemia of CKD not on dialysis. The first, an open-label Phase 3 conversion study versus active comparator, darbepoetin alfa, met the primary efficacy endpoint of non-inferiority and continued to demonstrate maintenance of hemoglobin (Hb) levels over time.1 Roxadustat was generally well tolerated, and the safety profile was comparable with that of darbepoetin alfa.1 The other two studies (one Phase 3 and one Phase 2) support the safety and efficacy of roxadustat in erythropoiesis-stimulating agent (ESA)-untreated patients.2,3
“Today’s approval is another milestone achievement for both FibroGen and Astellas,” said K. Peony Yu, M.D., Chief Medical Officer, FibroGen. “By bringing roxadustat to adult patients living with anemia of CKD, both on dialysis and not on dialysis, we are continuing our efforts to meet the significant unmet medical need of patients in this community.”
The approval of the supplementary New Drug Application (sNDA) for roxadustat in Japan for the treatment of anemia of CKD in adult patients not on dialysis triggers a milestone payment of $15 million by Astellas to FibroGen.
As a first-in-class orally administered inhibitor of hypoxia-inducible factor (HIF) prolyl hydroxylase (PH), roxadustat increases Hb levels through a mechanism of action that is different from that of traditional ESAs. As a HIF-PH inhibitor, roxadustat activates the body’s natural protective response to reduced oxygen levels in the blood. This response involves the regulation of multiple, coordinated processes that lead to the correction of anemia.
About Clinical Trials
About CKD and Anemia
Anemia is a common complication of CKD,10 resulting from the failing kidneys’ ability to produce erythropoietin, reduced oxygen sensing, and increased hepcidin and iron deficiency resulting from chronic inflammation. Anemia affects approximately one-third of Japanese patients with Stage 3–5 CKD.11 It is associated with significant morbidity and mortality in dialysis and non-dialysis populations, increasing in both prevalence and severity as kidney disease worsens.12 Anemia of CKD increases the risk of adverse cardiovascular events, worsens renal outcomes and can negatively impact patients’ quality of life.13-15
Roxadustat is approved and launched for the treatment of anemia of CKD in Japan and China in adult patients on dialysis (DD) and not on dialysis (NDD). A New Drug Application for the treatment of anemia of CKD in patients both DD and NDD is under review by the U.S. Food and Drug Administration with a decision expected in December 2020. The marketing authorisation application for roxadustat for the treatment of anemia of CKD in patients both DD and NDD was accepted by the European Medicines Agency for review on May 21, 2020. Several other licensing applications for roxadustat have been submitted by Astellas and AstraZeneca to regulatory authorities across the globe, which are currently in review.
Astellas and FibroGen are collaborating on the development and commercialization of roxadustat for the potential treatment of anemia in territories including Japan, Europe, Turkey, Russia and 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 in the Americas and in Australia/New Zealand as well as Southeast Asia.
Astellas Cautionary Notes
Information about pharmaceutical products (including products currently in development) that is included in this press release is not intended to constitute an advertisement or medical advice.
FibroGen Forward-Looking Statements
Contacts for inquiries or additional information:
Astellas Portfolio Communications
Astellas Pharma Inc.
1 Akizawa T, Iwasaki M, Otsuka T, et al. A Phase 3, Multicenter, Randomized, Open-label, Active Comparator Conversion Study of Roxadustat in Non–Dialysis-Dependent (NDD) Patients with Anemia in Chronic Kidney Disease (CKD). E-poster presented at the American Society of Nephrology Kidney Week Congress; October 22, 2020; US.
2 Akizawa T, Yamaguchi Y, Otsuka T, Reusch M. A Phase 3, Multicenter, Randomized, Two-Arm, Open-Label Study of Intermittent Oral Dosing of Roxadustat for the Treatment of Anemia in Japanese Erythropoiesis-Stimulating Agent-Naïve Chronic Kidney Disease Patients Not on Dialysis. Nephron 2020;144:372–382.
3 Akizawa T, Iwasaki M, Otsuka T, et al. Roxadustat Treatment of Chronic Kidney Disease-Associated Anemia in Japanese Patients Not on Dialysis: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial. Adv Ther 2019;36:1438–1454.
4 Ojo A. Addressing the Global Burden of Chronic Kidney Disease Through Clinical and Translational Research. Trans Am Clin Climatol Assoc 2014;125:229–246.
5 Tecklenborg J, Clayton D, Siebert S, and Coley SM. The role of the immune system in kidney disease. Clin Exp Immunol 2018; 192: 142–150.
6 International Society of Nephrology. Chronic Kidney Disease. Global Kidney Health Atlas 2017 [online]. Available from: www.theisn.org/global-atlas [Last accessed: October 2020].
7 Nagata M, Ninomiya T, Doi Y, et al. Trends in the prevalence of chronic kidney disease and its risk factors in a general Japanese population: The Hisayama Study. Nephrol Dial Transplant 2010;25:2557–2564.
8 Tonelli M, Riella M. Chronic kidney disease and the aging population. Indian J Nephrol 2014;24:71–74.
9 Institute for Health Metrics and Evaluation (IHME). Findings from the Global Burden of Disease Study 2017 [online] 2018. Available from: http://www.healthdata.org/sites/default/files/files/policy_report/2019/GBD_2017_Booklet.pdf [Last accessed: October 2020].
10 McClellan W, Aronoff SL, Kline Bolton W, et al. The prevalence of anemia in patients with chronic kidney disease. Curr Med Res Opin 2004;20:1501–1510.
11 Akizawa T, Okumura H, Alexandre AF, et al. Burden of Anemia in Chronic Kidney Disease Patients in Japan: A Literature Review. Ther Apher Dial 2018;22:444–456.
12 Stauffer ME, Fan T. Prevalence of Anemia in Chronic Kidney Disease in the United States. PLoS One 2014;9:e84943.
13 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;66:1131–1138.
14 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;44:198–206.
15 Eriksson D, Goldsmith D, Teitsson S, et al. Cross-sectional survey in CKD patients across Europe describing the association between quality of life and anaemia. BMC Nephrol 2016;17:97.
Session Details TBA
How to Get RoI from Your IoT
Protecting Critical Infrastructure with Epic Security