TOKYO, Japan and SAN FRANCISCO, CA, USA I October 01, 2018 I Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and FibroGen, Inc. (Nasdaq: FGEN, CEO: Thomas B. Neff, “FibroGen”) today announced that Astellas submitted a New Drug Application (NDA) for marketing approval in Japan of roxadustat (generic name, development code: ASP1517/FG-4592) for the treatment of anemia associated with Chronic Kidney Disease (CKD) in patients on dialysis. The results obtained from four Phase 3 studies conducted in CKD patients on dialysis in Japan support this NDA submission.
“We are pleased to report the submission of the Japan NDA for roxadustat as a treatment of anemia associated with CKD in patients on dialysis,” said Bernhardt G. Zeiher, M.D., Chief Medical Officer, Astellas. “We believe roxadustat offers a potential new oral therapeutic option for a condition which can have a debilitating impact on patients with renal disease.”
“We are excited about this critical advancement as we work together to bring this new therapy to patients with anemia associated with CKD in Japan,” said K. Peony Yu, M.D., Chief Medical Officer, FibroGen. “We appreciate the joint team’s dedicated effort and commitment to addressing important unmet medical needs of these patients and their physicians.”
Anemia is a common complication of CKD and is associated with significant morbidity and mortality in dialysis and non-dialysis populations. Anemia is a serious medical condition in which patients have insufficient red blood cells and low levels of hemoglobin (Hb), a protein in red blood cells that carries oxygen to cells throughout the body. Anemia is associated with increased risk of hospitalization, cardiovascular complications, need for blood transfusion, exacerbation of other serious medical conditions, and death. In addition, anemia frequently causes significant fatigue, cognitive dysfunction, and decreased quality of life. The more severe the anemia, as measured by lower Hb levels, the greater the health impact on patients. Treatment for anemia in CKD patients is a critical worldwide healthcare issue that represents a large and growing unmet medical need.
About Chronic Kidney Disease (CKD) and Anemia
CKD is estimated affect more than 200 million people worldwide*1 and specifically in Japan, the prevalence of CKD has increased significantly over time.*2 Although CKD can occur at any age, it becomes more common in aging populations, and the prevalence is increasing. Anemia is a common complication of CKD and is associated with significant morbidity and mortality in dialysis and non-dialysis populations. 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
Roxadustat, discovered and developed by FibroGen, is a compound currently in Phase 3 development on a global basis as a potential therapy for anemia associated with CKD in both patients on dialysis and not on dialysis. Roxadustat is an orally administered small molecule inhibitor of hypoxia-inducible factor (HIF) prolyl hydroxylase activity. HIF is a protein transcription factor that induces the natural physiological response to conditions of low oxygen, “turning on” erythropoiesis (the process by which red blood cells are produced).
Astellas and FibroGen are collaborating on the development of roxadustat for the potential treatment of anemia in patients with CKD and myelodysplastic syndromes 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 patients with CKD in the U.S., China, and other markets. For information about roxadustat studies, please visit clinicaltrials.gov at this link:
https://clinicaltrials.gov/ct2/results?term=roxadustat&Search=Search.
About Astellas
Astellas Pharma Inc., based in Tokyo, Japan, is a company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. For more information, please visit our website at https://www.astellas.com/en
About FibroGen
FibroGen, Inc., headquartered in San Francisco, with subsidiary offices in Beijing and Shanghai, is a leading biopharmaceutical company discovering and developing a pipeline of first-in-class therapeutics. The company applies its pioneering expertise in hypoxia-inducible factor (HIF), connective tissue growth factor (CTGF) biology, and clinical development to advance innovative medicines for the treatment of anemia, fibrotic disease, and cancer. Roxadustat, the company’s most advanced product candidate, is an oral small molecule inhibitor of HIF prolyl hydroxylase activity, completing worldwide Phase 3 clinical development for the treatment of anemia in chronic kidney disease (CKD), with a New Drug Application (NDA) currently under review by the State Drug Administration (SDA). Roxadustat is in Phase 3 clinical development in the U.S. and Europe and in Phase 2/3 development in China for anemia associated with myelodysplastic syndromes (MDS). Pamrevlumab, an anti-CTGF human monoclonal antibody, is advancing towards Phase 3 clinical development for the treatment of idiopathic pulmonary fibrosis (IPF) and pancreatic cancer, and is currently in a Phase 2 trial for Duchenne muscular dystrophy (DMD). FibroGen is also developing a biosynthetic cornea in China. For more information, please visit www.fibrogen.com.
1 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.
2 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.
SOURCE: Astellas Pharma
Post Views: 95
TOKYO, Japan and SAN FRANCISCO, CA, USA I October 01, 2018 I Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and FibroGen, Inc. (Nasdaq: FGEN, CEO: Thomas B. Neff, “FibroGen”) today announced that Astellas submitted a New Drug Application (NDA) for marketing approval in Japan of roxadustat (generic name, development code: ASP1517/FG-4592) for the treatment of anemia associated with Chronic Kidney Disease (CKD) in patients on dialysis. The results obtained from four Phase 3 studies conducted in CKD patients on dialysis in Japan support this NDA submission.
“We are pleased to report the submission of the Japan NDA for roxadustat as a treatment of anemia associated with CKD in patients on dialysis,” said Bernhardt G. Zeiher, M.D., Chief Medical Officer, Astellas. “We believe roxadustat offers a potential new oral therapeutic option for a condition which can have a debilitating impact on patients with renal disease.”
“We are excited about this critical advancement as we work together to bring this new therapy to patients with anemia associated with CKD in Japan,” said K. Peony Yu, M.D., Chief Medical Officer, FibroGen. “We appreciate the joint team’s dedicated effort and commitment to addressing important unmet medical needs of these patients and their physicians.”
Anemia is a common complication of CKD and is associated with significant morbidity and mortality in dialysis and non-dialysis populations. Anemia is a serious medical condition in which patients have insufficient red blood cells and low levels of hemoglobin (Hb), a protein in red blood cells that carries oxygen to cells throughout the body. Anemia is associated with increased risk of hospitalization, cardiovascular complications, need for blood transfusion, exacerbation of other serious medical conditions, and death. In addition, anemia frequently causes significant fatigue, cognitive dysfunction, and decreased quality of life. The more severe the anemia, as measured by lower Hb levels, the greater the health impact on patients. Treatment for anemia in CKD patients is a critical worldwide healthcare issue that represents a large and growing unmet medical need.
About Chronic Kidney Disease (CKD) and Anemia
CKD is estimated affect more than 200 million people worldwide*1 and specifically in Japan, the prevalence of CKD has increased significantly over time.*2 Although CKD can occur at any age, it becomes more common in aging populations, and the prevalence is increasing. Anemia is a common complication of CKD and is associated with significant morbidity and mortality in dialysis and non-dialysis populations. 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
Roxadustat, discovered and developed by FibroGen, is a compound currently in Phase 3 development on a global basis as a potential therapy for anemia associated with CKD in both patients on dialysis and not on dialysis. Roxadustat is an orally administered small molecule inhibitor of hypoxia-inducible factor (HIF) prolyl hydroxylase activity. HIF is a protein transcription factor that induces the natural physiological response to conditions of low oxygen, “turning on” erythropoiesis (the process by which red blood cells are produced).
Astellas and FibroGen are collaborating on the development of roxadustat for the potential treatment of anemia in patients with CKD and myelodysplastic syndromes 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 patients with CKD in the U.S., China, and other markets. For information about roxadustat studies, please visit clinicaltrials.gov at this link:
https://clinicaltrials.gov/ct2/results?term=roxadustat&Search=Search.
About Astellas
Astellas Pharma Inc., based in Tokyo, Japan, is a company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. For more information, please visit our website at https://www.astellas.com/en
About FibroGen
FibroGen, Inc., headquartered in San Francisco, with subsidiary offices in Beijing and Shanghai, is a leading biopharmaceutical company discovering and developing a pipeline of first-in-class therapeutics. The company applies its pioneering expertise in hypoxia-inducible factor (HIF), connective tissue growth factor (CTGF) biology, and clinical development to advance innovative medicines for the treatment of anemia, fibrotic disease, and cancer. Roxadustat, the company’s most advanced product candidate, is an oral small molecule inhibitor of HIF prolyl hydroxylase activity, completing worldwide Phase 3 clinical development for the treatment of anemia in chronic kidney disease (CKD), with a New Drug Application (NDA) currently under review by the State Drug Administration (SDA). Roxadustat is in Phase 3 clinical development in the U.S. and Europe and in Phase 2/3 development in China for anemia associated with myelodysplastic syndromes (MDS). Pamrevlumab, an anti-CTGF human monoclonal antibody, is advancing towards Phase 3 clinical development for the treatment of idiopathic pulmonary fibrosis (IPF) and pancreatic cancer, and is currently in a Phase 2 trial for Duchenne muscular dystrophy (DMD). FibroGen is also developing a biosynthetic cornea in China. For more information, please visit www.fibrogen.com.
1 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.
2 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.
SOURCE: Astellas Pharma
Post Views: 95
