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:Biotechnology headlines - Category: Biotechnology Authors: Source Type: news

Related Links:

Conclusion: CKD patients have a high morbidity of ESS, mainly low T3 syndrome. Anemia, inflammation, and malnutrition may contribute to ESS in CKD.Kidney Blood Press Res
Source: Kidney and Blood Pressure Research - Category: Urology & Nephrology Source Type: research
Fight Aging! provides a weekly digest of news and commentary for thousands of subscribers interested in the latest longevity science: progress towards the medical control of aging in order to prevent age-related frailty, suffering, and disease, as well as improvements in the present understanding of what works and what doesn't work when it comes to extending healthy life. Expect to see summaries of recent advances in medical research, news from the scientific community, advocacy and fundraising initiatives to help speed work on the repair and reversal of aging, links to online resources, and much more. This content is...
Source: Fight Aging! - Category: Research Authors: Tags: Newsletters Source Type: blogs
Authors: Kuragano T, Mizusaki K, Kimura T, Nakanishi T Abstract The results of previous large clinical trials have revealed that low hemoglobin (Hb) levels are significantly associated with adverse events (cardiovascular disease, infection, hospitalization, and mortality) in patients with chronic kidney disease (CKD). However, in the general population, the mean Hb levels differ by sex and age. Furthermore, the comorbidities and activities of daily living of elderly patients are markedly different from those of nonelderly patients. CKD in elderly patients is accompanied by not only chronic inflammation, which is mo...
Source: Contributions to Nephrology - Category: Urology & Nephrology Tags: Contrib Nephrol Source Type: research
The link between age-related kidney dysfunction and cognitive impairment is an interesting one, particularly in the context of research into klotho, which has functions in both the kidney and the brain, and has been shown to extend life and improve cognitive function in animal studies. It isn't completely clear as to which of these areas of the body is most important to the noted benefits to cognitive function in animal models, produced via various strategies for klotho overexpression. The most recent research on this topic tends to suggest that the mechanisms are indirect, involving many organ systems, rather than being a...
Source: Fight Aging! - Category: Research Authors: Tags: Daily News Source Type: blogs
We report the long-term effects of treatment with atrasentan on major renal outcomes.MethodsWe did this double-blind, randomised, placebo-controlled trial at 689 sites in 41 countries. We enrolled adults aged 18–85 years with type 2 diabetes, estimated glomerular filtration rate (eGFR) 25–75 mL/min per 1·73 m2 of body surface area, and a urine albumin-to-creatinine ratio (UACR) of 300–5000 mg/g who had received maximum labelled or tolerated renin–angiotensin system inhibition for at least 4 weeks. Participants were given atrasentan 0·75 mg orally daily during an enrichment period befor...
Source: The Lancet - Category: General Medicine Source Type: research
Iron deficiency anemia is a common complication of chronic kidney disease (CKD). CKD patients suffer from both absolute and functional iron deficiency. Absolute iron deficiency is defined by severely reduced or absent iron stores, while functional iron deficiency is defined by adequate iron stores but insufficient iron availability for incorporation into erythroid precursors. This is due to increased levels of hepcidin. Anemia in CKD is associated with an increased risk of morbidity and mortality. The association between anemia and mortality may be related to the severity of anemia. All CKD patients should be screened for ...
Source: Acta Haematologica - Category: Hematology Source Type: research
Abstract Iron deficiency anemia is a common complication of chronic kidney disease (CKD). CKD patients suffer from both absolute and functional iron deficiency. Absolute iron deficiency is defined by severely reduced or absent iron stores, while functional iron deficiency is defined by adequate iron stores but insufficient iron availability for incorporation into erythroid precursors. This is due to increased levels of hepcidin. Anemia in CKD is associated with an increased risk of morbidity and mortality. The association between anemia and mortality may be related to the severity of anemia. All CKD patients shoul...
Source: Acta Haematologica - Category: Hematology Authors: Tags: Acta Haematol Source Type: research
CONCLUSIONS: Using CBC design for the first time in a non-interventional ESA study with an electronic Patient Reported Outcome (ePRO) in an elderly population, these data showed that monthly injections and treatment efficacy were key patients' expectations relative to ESAs. CERA efficacy to maintain stable haemoglobin within the recommended range was confirmed in real-life conditions. PMID: 30962139 [PubMed - as supplied by publisher]
Source: Nephrologie and Therapeutique - Category: Urology & Nephrology Authors: Tags: Nephrol Ther Source Type: research
This study evaluated efficacy and safety/tolerability of roxadustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, in Japanese anemic non-dialysis-dependent chronic kidney disease (NDD-CKD) patients.MethodsIn this phase 2, double-blind, 24-week study, NDD-CKD patients were randomized to oral placebo or roxadustat (50, 70, or 100  mg) three times weekly (TIW) for 6 weeks followed by dose adjustments to maintain hemoglobin (Hb) at 10–12 g/dL for 18 weeks; patients meeting pre-defined criteria were re-randomized to TIW or once-weekly dosing. The primary end point was rate of rise of ...
Source: Advances in Therapy - Category: Drugs & Pharmacology Source Type: research
Condition:   Chronic Kidney Diseases Interventions:   Drug: Pegol-Sihematide;   Drug: ESPO Sponsor:   Jiangsu Hansoh Pharmaceutical Co., Ltd. Not yet recruiting
Source: ClinicalTrials.gov - Category: Research Source Type: clinical trials
More News: Anemia | AstraZeneca | Biotechnology | China Health | Chronic Kidney Disease | Dialysis | Health Management | Urology & Nephrology