FibroGen China has also completed a roxadustat China Phase 3 placebo-controlled trial innon-dialysis-dependent (NDD) CKD patients. The addition of NDD patients to the label is expected once regulatory inspections of the clinical trial sites by the NMPA are completed.
Anemia commonly develops in association with CKD. Based on a large-scale cross-sectional survey performed between September 2009 and September 2010 and published in theLancet, there are an estimated 120 million CKD patients in China, including estimated 0.5 million patients on dialysis who may be suffering from anemia, a number that is increasing significantly.2,3
AstraZeneca and FibroGen China are collaborating on the development and commercialization of roxadustat in China. FibroGen China, based in Beijing, is a subsidiary of FibroGen, Inc. that sponsored the development and registration of roxadustat as a Domestic Class 1 Innovative Drug. FibroGen China conducted the China Phase 3 clinical trials and submitted the New Drug Application for registration of roxadustat to the Chinese regulatory authorities. Following this approval, AstraZeneca will manage commercialization activities in China, and FibroGen China will manage commercial manufacturing and medical affairs as well as continued clinical development and regulatory affairs. AstraZeneca and FibroGen expect to launch roxadustat in China in the second half of 2019.
About Roxadustat
Roxadustat(FG-4592), discovered by FibroGen, is afirst-in-class, orally administered small molecule currently approved in China for the treatment of patients with anemia from CKD on dialysis. Roxadustat is aHIF-PHI that promotes erythropoiesis through increasing endogenous production of erythropoietin, improving iron regulation, and overcoming the negative impact of inflammation on hemoglobin syntheses and red blood cell production by downregulating hepcidin. Administration of roxadustat has been shown to induce coordinated erythropoiesis, increasing red blood cell count while maintaining plasma erythropoietin levels within or near normal physiologic range in multiple subpopulations of CKD patients, including in the presence of inflammation and without a need for supplemental intravenous iron. Roxadustat was well tolerated in the China Phase 3 studies. The adverse events observed were consistent with underlying diseases in patients with CKD.
FibroGen, the originator, and AstraZeneca are collaborating on the development and commercialization of roxadustat for the treatment of anemia in the U.S., China, and other markets in the Americas, Australia, New Zealand and Southeast Asia. FibroGen and Astellas Pharma Inc. and FibroGen are collaborating on the development and commercialization of roxadustat for the treatment of anemia in territories including Japan, Europe, the Commonwealth of Independent States, the Middle East, and South Africa.
About Anemia Associated with CKD in China
Anemia commonly develops in association with chronic kidney disease and is linked to significant morbidity and mortality in both the dialysis andnon-dialysis populations. Although CKD may occur at any age, it is more common in aging populations, and its prevalence is increasing. CKD can be both a cause and a consequence of cardiovascular disease and is a critical healthcare issue. There is no treatment available that is curative, or has the ability to stop kidney deterioration.
About FibroGen
FibroGen, Inc., headquartered in San Francisco, California, with subsidiary offices in Beijing and Shanghai, People’s Republic of China, is a leading biopharmaceutical company discovering and developing a pipeline offirst-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) now approved by the
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