Why a kidney disease drug approval in China is just the start for this S.F. company

To win its first-ever drug approval, FibroGen Inc. turned to China, but it's not going to be the San Francisco company's last stop. China's drug regulatory agency Monday approved roxadustat, the first drug of its kind for dialysis patients with anemia caused by chronic kidney disease. San Francisco-based FibroGen's (NASDAQ: FGEN) China subsidiary will manufacture the tablet and partner AstraZeneca plc (NYSE: AZN) will sell the drug starting in the second-half of 2019. But roxadustat's win in China…
Source: bizjournals.com Health Care:Physician Practices headlines - Category: American Health Authors: Source Type: news

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Patients with chronic kidney disease (CKD) have an increased risk of adverse cardiovascular/cerebrovascular events. The aim of this study is to clarify whether stress myocardial perfusion single-photon emission computed tomography (SPECT) could predict cardiovascular/cerebrovascular events. In the Gunma-CKD SPECT Study, a multicenter prospective cohort trial, 311 patients with CKD (estimated glomerular filtration rate #x3c; 60 min/mL/1.73 m2) including 50 patients on hemodialysis underwent stress99mTc-tetrofosmin SPECT for suspected ischemic heart disease and were followed for 2 years. The primary endpoint was the occurren...
Source: Cardiology - Category: Cardiology Source Type: research
The objective of this study was to compare the eff...
Source: BMC Nephrology - Category: Urology & Nephrology Authors: Tags: Research article Source Type: research
Conclusions: Molidustat was well tolerated for up to 36 months and appears to be an effective alternative to darbepoetin and epoetin in the long-term management of anemia associated with CKD.Am J Nephrol 2019;49:271 –280
Source: American Journal of Nephrology - Category: Neurology Source Type: research
CONCLUSIONS: Molidustat was well tolerated for up to 36 months and appears to be an effective alternative to darbepoetin and epoetin in the long-term management of anemia associated with CKD. PMID: 30852574 [PubMed - as supplied by publisher]
Source: American Journal of Nephrology - Category: Urology & Nephrology Authors: Tags: Am J Nephrol Source Type: research
CONCLUSIONS: ESA-treated patients undergoing dialysis incurred lower costs, lower HRU, and had better HRQoL relative to ESA-untreated patients. However, treatment to higher Hb targets led to modest HRQoL improvements compared to lower Hb targets. PMID: 30813807 [PubMed - as supplied by publisher]
Source: Journal of Medical Economics - Category: Health Management Tags: J Med Econ Source Type: research
Abstract Chronic kidney disease (CKD) is associated with several complications that worsen with progression of disease; anemia, disturbances in iron metabolism and inflammation are common features. Inflammatory response starts early, releasing pro-inflammatory cytokines, acute phase reactants and hepcidin. Hepcidin production is modulated by several factors, as hypoxia/anemia, erythropoietin and erythropoiesis products, transferrin saturation (TSAT) and liver iron levels, which are altered in CKD. Treatment of CKD anemia is based on pharmaceutical intervention, with erythropoietic stimulating agents and/or iron su...
Source: Vitamins and Hormones - Category: Endocrinology Authors: Tags: Vitam Horm Source Type: research
CONCLUSIONS: A simple and easy-to-use risk prediction tool utilizing standard clinical parameters identifies TAVR patients at increased risk of 30-day readmission. The tool may consequently inform hospital discharge planning, optimize transitions of care, and reduce resource utilization. PMID: 30803938 [PubMed - as supplied by publisher]
Source: EuroIntervention - Category: Cardiovascular & Thoracic Surgery Tags: EuroIntervention Source Type: research
This article summarizes the milestones in the development of roxadustat leading to this first approval.
Source: Drugs - Category: Drugs & Pharmacology Source Type: research
Ferumoxytol for iron deficiency anemia in patients undergoing hemodialysis. The FACT randomized controlled trial
. Clin Nephrol. 2019 Feb 25;: Authors: Macdougall IC, Strauss WE, Dahl NV, Bernard K, Li Z Abstract BACKGROUND: Patients with chronic kidney disease (CKD) undergoing dialysis often require intravenous iron for iron deficiency anemia (IDA). MATERIALS AND METHODS: The Ferumoxytol for Anemia of CKD Trial (FACT), a randomized, multicenter, open-label, phase 4 study, compared the long-term safety and efficacy of ferumoxytol with iron sucrose for the treatment of IDA in patients ...
Source: Clinical Nephrology - Category: Urology & Nephrology Authors: Tags: Clin Nephrol Source Type: research
Abstract INTRODUCTION: The FIND-CKD study has validated the use of ferric carboxymaltose (FCM) injection with a target of ferritin level between 400 and 600ng/mL to treat iron deficiency anemia in non-dialysis-dependent chronic kidney disease (ND-CKD) patients. In order to assess this strategy in clinical practice, we constituted a cohort of patients within our nephrology department. PATIENTS AND METHODS: Patients had CKD stages 3 to 5, hemoglobin level (Hb)
Source: Nephrologie and Therapeutique - Category: Urology & Nephrology Authors: Tags: Nephrol Ther Source Type: research
More News: American Health | Anemia | AstraZeneca | China Health | Chronic Kidney Disease | Dialysis | Health Management | Urology & Nephrology