TMCnet News
FibroGen Announces Completion of Enrollment in U.S. Phase 3 Clinical Program for Roxadustat in Anemia Associated with Chronic Kidney DiseaseSAN FRANCISCO, June 07, 2018 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ:FGEN), a biopharmaceutical company, today announced the completion of patient enrollment in the Phase 3 studies supporting the U.S. new drug application (NDA) submission for roxadustat in anemia associated with chronic kidney disease (CKD). The Phase 3 clinical program is evaluating the use of roxadustat for the treatment of anemia in both dialysis-dependent and non-dialysis-dependent CKD patients. “We are pleased to have achieved this critical step in our roxadustat Phase 3 clinical program, and we look forward to reporting topline results from these studies by the end of this year, with pooled safety analyses available in 2019,” said K. Peony Yu, Chief Medical Officer, FibroGen. “The results of these studies will support the submission of an NDA in the first half of 2019.” A total of approximately 9,000 CKD patients were enrolled across the seven studies sponsored by FibroGen and its partners Astellas Pharma Inc. and AstraZeneca in both dialysis-dependent patients and non-dialysis-dependent patients. Subpopulations of interest include patients initiating dialysis (incident dialysis) and patients with inflammation. Previously reported results from extensive Phase 2 studies and Phase 3 studies from China and from Japan have shown roxadustat to be effective in correcting and/or maintaining hemoglobin levels in various populations of CKD patients with anemia. Roxadustat has shown positive effects on iron metabolism, and the ability to correct and maintain hemoglobin levels without requiring concomitant administration of intravenous iron. Roxadustat has been well-tolerated in all studies to date. “This is an exciting time for us as we advance the first oral therapy for anemia in CKD one step closer to patients,” said Thomas B. Neff, Chief Executive Officer, FibroGen. “Our goal is to provide these patients and those who care for them with a new therapeutic option with the potential to be safer, more effective, more convenient, and more accessible than currently available therapies.” About CKD and Anemia Anemia is particularly prevalent in patients with CKD, which is a critical healthcare problem in the U.S. and Europe, and most commonly caused by diabetes and hypertension. CKD affects more than 200 million people worldwide and significantly increases healthcare costs for those patients. CKD is generally a progressive disease characterized by gradual loss of kidney function that may eventually lead to kidney failure, which is also known as end-sage renal disease (“ESRD”). Patients with ESRD require renal replacement therapy — either dialysis treatment or kidney transplantation. CKD accompanied by anemia is associated with worse health outcomes than CKD alone, including more rapid disease progression and an increased death rate. There are five stages of CKD that are primarily defined by a measure of the filtration function of the kidney (GFR). In the U.S., according to the USRDS, a majority of dialysis eligible CKD patients are currently on dialysis. Of the approximately 475,000 patients receiving dialysis in the U.S., approximately 83% were being treated with ESAs for anemia. Despite the presence of anemia in stages 3 and 4 CKD patients, in clinical practice, patients typically do not receive ESA treatment for their anemia until they initiate dialysis. As of 2014, approximately 14% of U.S. NDD-CKD patients were being treated with ESAs prior to initiation of dialysis (2016 USRDS ADR). In many CKD patients, the disease progresses gradually over decades and patients can spend years suffering from the symptoms and negative health effects of anemia before they receive treatment. Many of these patients die from cardiovascular events before they initiate dialysis. About Roxadustat Astellas and FibroGen are collaborating on the development and commercialization of roxadustat for the treatment of anemia in patients with CKD in territories including Japan, Europe, the Commonwealth of Independent States, the Middle East, and South Africa. AstraZeneca and FibroGen are collaborating on the development and commercialization of roxadustat for the treatment of anemia in patients with CKD in the U.S., China, and other markets. Roxadustat is currently advancing through Phase 3 clinical trials worldwide, supported by extensive Phase 2 clinical data demonstrating correction and maintenance of hemoglobin levels in multiple subpopulations of CKD anemia patients. Globally, the Phase 3 program encompasses a total of 15 Phase 3 studies to support independent regulatory approvals of roxadustat in both non-dialysis-dependent and dialysis-dependent CKD patients in the U.S., Europe, Japan, and China. About FibroGen Forward-Looking Statements Contact
|