Roxadustat Positive Pooled Phase 3 Efficacy and Cardiovascular Safety Data Presented Last Friday at American Society of Nephrology 2019 Kidney WeekPlan to Submit Roxadustat U.S. NDA This QuarterConference Call Today at 5:00 p.m. Eastern Time/2:00 p.m. Pacific TimeSAN FRANCISCO, Nov. 11, 2019 (GLOBE NEWSWIRE) — FibroGen, Inc. (NASDAQ: FGEN) today reported financial results for the third quarter of 2019 and provided an update on the company’s recent developments.“The FibroGen team achieved many milestones over the past few months, culminating with the positive Phase 3 results for roxadustat reported at the American Society of Nephrology conference last week in Washington, D.C.,” said Jim Schoeneck, Interim Chief Executive Officer, FibroGen. “This set of global studies covered the spectrum of chronic kidney disease anemia and is believed to be the largest and most comprehensive ever reported. We expect the positive cardiovascular safety data, comparing roxadustat to placebo in non-dialysis patients and to epoetin alfa in patients on dialysis, along with the superior efficacy results, can serve as the basis for regulatory approval in the U.S. and other jurisdictions. We plan to submit an NDA in the U.S. by the end of this quarter for both dialysis and non-dialysis patients with our partner AstraZeneca, and an MAA in Europe by the end of first quarter 2020 by our partner Astellas, followed by submissions to other regulatory authorities.“In addition, roxadustat is now approved for CKD patients with anemia in China and was approved in Japan for anemia in CKD patients on dialysis. Our other clinical programs advanced, as we initiated our roxadustat Phase 2 study to treat anemia in patients receiving chemotherapy and enrolled the first patients in our pamrevlumab Phase 3 programs for both idiopathic pulmonary fibrosis (ZEPHYRUS) and locally advanced pancreatic cancer (LAPIS).“These major accomplishments demonstrate our commitment to the vision set by FibroGen’s founder and long-time CEO and Chairman, Tom Neff. We mourn his unexpected passing and are grateful for his leadership and rare ability to recognize and advance scientific innovation.”
Recent Developments – RoxadustatRoxadustat is a novel, oral, first-in-class treatment for chronic kidney disease (CKD) patients with anemia, discovered by FibroGen and developed globally in conjunction with our partners AstraZeneca and Astellas. Groundbreaking science on the body’s oxygen-sensing mechanism and adaptation to hypoxia was awarded the 2019 Nobel Prize in Physiology or Medicine and serves as the foundation for the mechanism of action for roxadustat. Roxadustat increases hemoglobin by mimicking the body’s natural response to low oxygen.American Society of Nephrology Kidney Week Presentations – November 6-9, 2019Clinical results presented from six roxadustat Phase 3 studies comprising over 8,000 anemia patients with chronic kidney disease, as well as pooled results for patients not on dialysis and on dialysis, including an incident dialysis subgroupFor additional data presented, please see our November 8, 2019 press release
Please also see our website for FibroGen’s ASN presentations
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