Blog Exposure – FibroGen Completed Enrollment in US Phase-3 Clinical Program for Roxadustat in CKD Associated Anemia

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LONDON, UK / ACCESSWIRE / June 11, 2018 / If you want access to our free research report on FibroGen, Inc. (NASDAQ: FGEN), all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/?symbol=FGEN as the Company’s latest news hit the wire. On June 07, 2018, the Company announced that it has completed patient enrollment in the Phase-3 studies supporting the US new drug application (NDA) submission for Roxadustat in anemia associated with chronic kidney disease (CKD). Register today and get access to over 1,000 Free Research Reports by joining our site below:

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FibroGen to Report Top-line Results from Roxadustat Phase-3 Program by End of 2018

Commenting on the announcement, K. Peony Yu, Chief Medical Officer of FibroGen, stated that the Company is pleased to have achieved this critical step in its roxadustat Phase-3 clinical program, and FibroGen looks forward to reporting top-line results from these studies by the end of this year, with pooled safety analyses available in 2019.

Peony added that the results of these studies will support the submission of an NDA in the first half of 2019.

Phase-3 Clinical Program is Evaluating Use of Roxadustat for Treatment of Anemia in both Dialysis-Dependent and Non-Dialysis-Dependent CKD Patients

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. A total of around 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.

CFDA Accepted FibroGen’s Marketing Application for Roxadustat

In October 2017, the China Food and Drug Administration (CFDA) accepted FibroGen’s submitted NDA for registration of roxadustat for investigational treatment for anemia in dialysis-dependent CKD and non-dialysis-dependent CKD patients. The NDA for roxadustat was based on the results of FibroGen’s two Phase-3 multi-center, randomized, controlled studies conducted in China, one study in CKD dialysis comparing roxadustat against a branded epoetin alfa, and one study in CKD non-dialysis comparing roxadustat against placebo. Both of the Phase-3 studies met their primary efficacy endpoints with no new or unexpected safety signals identified.

Astellas and FibroGen Collaboration

FibroGen and Astellas have been collaborating on hypoxia-inducible factor (HIF) anemia programs since 2004, first for Japan, and then for a broader territory covering Europe, Middle-East, the Commonwealth of Independent States, and South Africa. The strategic collaboration between the two companies brought the roxadustat programs to Phase-3 clinical development first among all HIF prolyl hydroxylase inhibitor (HIF-PHI) programs. In 2013, FibroGen and AstraZeneca entered into an anemia partnership for the US, and all other markets not licensed to Astellas, and for China.

About Anemia and CKD

Anemia is a serious medical condition in which patients have insufficient red blood cells and low levels of hemoglobin, 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. Severe anemia is common in patients with CKD, cancer, MDS, inflammatory diseases, and other serious illnesses.

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-stage 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.

About Roxadustat

Roxadustat (FG-4592) is a first-in-class, orally administered small molecule currently in global Phase-3 clinical development as a potential therapy for anemia associated with CKD. Roxadustat is a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) that promotes erythropoiesis through increasing endogenous erythropoietin, improving iron regulation, and reducing 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.

About FibroGen, Inc.

Founded in 1993 and headquartered in San Francisco, California, FibroGen is a leading science-based biopharmaceutical company discovering and developing a pipeline of first-in-class therapeutics. The Company applies its pioneering expertise in fibrosis and HIF biology and clinical development to advance innovative medicines for the treatment of anemia, fibrotic disease and cancer.

Stock Performance Snapshot

June 08, 2018 – At Friday’s closing bell, FibroGen’s stock advanced 3.76%, ending the trading session at $57.90.

Volume traded for the day: 424.92 thousand shares.

Stock performance in the last month – up 20.37%; previous three-month period – up 4.42%; past twelve-month period – up 98.63%; and year-to-date – up 22.15%

After last Friday’s close, FibroGen’s market cap was at $4.73 billion.

The stock is part of the Healthcare sector, categorized under the Biotechnology industry. This sector was up 0.6% at the end of the session.

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