FibroGen, Inc. (FGEN) today announced that FibroGen (China) Medical Technology Development Co., Ltd. (FibroGen China) has received marketing authorization from the National Medical Products Administration (NMPA) for roxadustat, a first-in-class hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) for the treatment of patients with anemia caused by chronic kidney disease (CKD) in patients who are dialysis-dependent (DD). The medicine can be prescribed to patients who use hemodialysis or peritoneal dialysis.
Anemia caused by CKD is associated with cardiovascular disease, hospitalization, cognitive impairment, and reduced quality of life, and has been shown consistently to increase the mortality risk in patients with CKD.1 Anemia becomes increasingly common among individuals with CKD as their disease progresses, affecting nearly all patients at the dialysis-eligible stage.1
Thomas B. Neff, Chief Executive Officer, FibroGen, said: “We believe roxadustat will make a significant difference for patients in China by addressing a substantial unmet medical need in the treatment of anemia associated with chronic kidney disease. This is an exciting milestone, as we are realizing our decade-long commitment to bringing innovative medicine to people in China. We look forward to bringing roxadustat to patients worldwide.”
Chris Chung, Managing Director, FibroGen China, said: “We are grateful to the patients and physicians in China who participated in our clinical studies. Almost ten years ago, FibroGen made the decision to develop roxadustat, a first-in-class investigational candidate, in China as a Domestic Class 1 Innovative Drug. It arose out of a commitment to give Chinese patients accelerated access to critically needed innovative medicines.”
Roxadustat (China Approved Drug Name: 罗沙司他; Chinese brand name: 爱瑞卓®) is the first approved oral HIF-PHI medicine. This approval is supported by an open-label, active-control 26-week Phase 3 trial in DD-CKD patients with anemia who were previously treated with various forms of locally manufactured injectable recombinant erythropoietin products. In the trial, these DD-CKD patients were then randomized to receive either roxadustat or ESPO® (利血宝®) brand epoetin alfa, manufactured and marketed by Kyowa Hakko Kirin.
FibroGen China has also completed a roxadustat China Phase 3 placebo-controlled trial in non-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 the Lancet, 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.
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