Arian Kemp According to the United States Renal Data System, about 80% of the approximately 507,000 patients receiving dialysis in the US in 2016 were being treated with erythropoiesis-stimulating agents (ESA).5 Patients seldom receive ESA treatment until they initiate dialysis therapy. It occurs when the body has fewer healthy red blood cells than normal and low levels of haemoglobin, which may leave patients fatigued and short of breath. Adrian Kemp AstraZeneca today presented detailed results from the Phase III OLYMPUS and ROCKIES trials showing that roxadustat significantly increased haemoglobin (Hb) levels in non-dialysis-dependent (NDD) and dialysis-dependent (DD) patients with anaemia from chronic kidney disease (CKD), respectively. Patients treated with roxadustat used less monthly intravenous (IV) iron (mean = 59mg) compared to those treated with epoetin alfa (mean = 91mg) from week 36 to the end of the study. Clinicaltrials.gov. United States Renal Data System. Last accessed: September 2018. Results from OLYMPUS and ROCKIES reinforce the potential role that roxadustat could play in increasing haemoglobin levels and managing anaemia, which is often underdiagnosed and undertreated.”, Steven Fishbane, MD, Zucker School of Medicine at Hofstra/Northwell, Great Neck, New York, US and primary investigator on the OLYMPUS and ROCKIES trials, said: “These data demonstrated that roxadustat effectively increased haemoglobin levels for patients with anaemia from chronic kidney disease, including those who show signs of inflammation. OLYMPUS is a Phase III, randomised, double-blinded, placebo-controlled trial designed to evaluate the efficacy and safety of roxadustat vs. placebo for the treatment of patients with anaemia in CKD stages 3, 4 and 5 whose disease progression is moderate to severe and who are non-dialysis dependent.1 The trial … In the OLYMPUS study, investigators found that roxadustat … This website is intended for people seeking information on AstraZeneca's worldwide business. Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: “Anaemia is a common, serious condition among patients with chronic kidney disease. Today's win in the European Alps trial will help its cause – but a safety analysis of the … About AstraZeneca in Cardiovascular, Renal & Metabolism (CVRM). AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, Cardiovascular, Renal & Metabolism and Respiratory. If this delays dialysis initiation, patients have more time to get a transplant. Roxadustat is in global Phase 3 clinical development in the U.S. and Europe and in Phase 2/3 development in China for anemia associated with myelodysplastic syndromes (MDS), and in a Phase 2 U.S. trial … The global Phase III programme consists of more than 9,000 patients in trials conducted by AstraZeneca, FibroGen and Astellas. By following the science to understand more clearly the underlying links between the heart, kidneys and pancreas, AstraZeneca is investing in a portfolio of medicines to protect organs and improve outcomes by slowing disease progression, reducing risks and tackling co-morbidities. FibroGen and Astellas Pharma Inc. (Astellas) are collaborating on the development and commercialisation of roxadustat for the treatment of anaemia in patients with CKD in territories including Japan, Europe, the Commonwealth of Independent States, the Middle East, and South Africa. In the OLYMPUS trial, investigators compared the drug with a placebo, while the ROCKIES trial compared roxadustat to epoetin alfa. “Anaemia in Chronic Kidney Disease.” 2014. CKD affects more than 200 million patients worldwide and is generally a progressive disease characterised by gradual loss of kidney function that may eventually lead to kidney failure. You have selected a link that will take you to a site maintained by a third party who is solely responsible for its contents. Any reference in these archives to AstraZeneca products or their uses may not reflect current medical knowledge and should not be used as a source of information on the present product label, efficacy data or safety data. The results were presented today during two oral sessions at the American Society of … Among 2,781 patients not on dialysis in the OLYMPUS trial, roxadustat also showed superior hemoglobin changes from baseline to the averaged levels across weeks 28-52 versus … United States Renal Data System. For all patients, the most frequently reported adverse events in the intent to treat analysis set were end-stage renal disease, pneumonia, urinary tract infection and hypertension. Roxadustat is a HIF-PHI that promotes erythropoiesis by increasing endogenous production of erythropoietin and improving iron regulation and overcoming the negative impact of inflammation on haemoglobin synthesis and red blood cell production by downregulating hepcidin. Available at: https://clinicaltrials.gov/ct2/show/record/NCT02174627. Roxadustat is a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) and a potential first-in-class new medicine to treat anaemia in CKD being jointly developed and commercialised by AstraZeneca and FibroGen, Inc. OLYMPUS is a Phase III, randomised, double-blinded, placebo-controlled trial designed to evaluate the efficacy and safety of roxadustat vs. placebo for the treatment of patients with anaemia in CKD stages 3, 4 and 5 whose disease progression is moderate to severe and who are non-dialysis dependent.1 The trial met its primary efficacy endpoint by demonstrating a statistically-significant and clinically-meaningful improvement in mean change from baseline in haemoglobin (Hb) levels averaged over weeks 28 to 52 vs. placebo.1 The trial evaluated 2,781 patients in 26 countries. Mechanisms of Anemia in CKD. Of the approximately 507,000 patients receiving dialysis in the US as of 2016, approximately 80% were being treated with ESAs for anaemia.7 Patients seldom receive ESA treatment until they initiate dialysis therapy. Use 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 IV iron. Anaemia can be a serious medical condition in which patients have insufficient red blood cells and low levels of Hb, a protein in red blood cells that carries oxygen to cells throughout the body.3,4 Anaemia in CKD is associated with increased risk of hospitalisation, cardiovascular complications and death,5 also frequently causing significant fatigue, cognitive dysfunction and decreased quality of life.6 Severe anaemia is common in patients with CKD, cancer, myelodysplastic syndrome, inflammatory diseases, and other serious illnesses. Please refer to your approved national product label (SmPC) for current product information. The results were presented today during two oral sessions at the American Society of Nephrology (ASN) Kidney Week 2019 in Washington, D.C., US. The OLYMPUS trial compared roxadustat to placebo while the ROCKIES trial compared roxadustat to epoetin alfa. Adverse events with roxadustat were generally similar to those seen in patients treated with epoetin alfa and commonly found in DD-CKD patients. KDOQI Clinial Practice Guidelines and Clinical Practice Recommendations for Anaemia in Chronic Kidney Disease. 7 November 2019 -- AstraZeneca today presented detailed results from the Phase III OLYMPUS and ROCKIES trials showing that roxadustat significantly increased hemoglobin (Hb) levels in both non … The OLYMPUS trial compared roxadustat to placebo while the ROCKIES trial compared roxadustat to epoetin alfa. 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 (IV) iron. 2021 Mar;32(3):737-755. doi: … “Managing Anaemia When You Have Kidney Disease or Kidney Failure.” 2014. You have selected a link that will take you to a site maintained by a third party who is solely responsible for its contents. Cardiovascular, renal and metabolism together form one of AstraZeneca’s main therapy areas and a key growth driver for the Company. Any reference in these archives to AstraZeneca products or their uses may not reflect current medical knowledge and should not be used as a source of information on the present product label, efficacy data or safety data. National Kidney Foundation. AstraZeneca today announced that the Phase III OLYMPUS and ROCKIES trials for roxadustat each met their primary efficacy endpoints for the treatment of patients with anaemia in chronic kidney disease (CKD) that are either non-dialysis-dependent or dialysis-dependent, respectively. The OLYMPUS trial compared roxadustat to placebo while the ROCKIES trial compared roxadustat to epoetin alfa. ROCKIES evaluated 2,133 DD-CKD patients with anaemia either currently treated with an erythropoietin analogue (Hb<12g/dL) or not currently treated with an erythropoietin analogue (Hb<10g/dL) randomised 1:1 to roxadustat or epoetin alfa across 18 countries. Available at: https://clinicaltrials.gov/ct2/show/record/NCT02174731. OLYMPUS is a Phase III, randomised, double-blinded, placebo-controlled trial designed to evaluate the efficacy and safety of roxadustat vs. placebo for the treatment of patients with … AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, CVRM, and Respiratory. AstraZeneca is not responsible for the privacy policy of any third party websites. Results from these trials will be presented at forthcoming medical meetings. By following the science to understand more clearly the underlying links between the heart, kidneys and pancreas, AstraZeneca is investing in a portfolio of medicines to protect organs and improve outcomes by slowing disease progression, reducing risks and tackling co-morbidities. Click ‘cancel’ to return to AstraZeneca’s site or ‘continue’ to proceed. Roxadustat is a first-in-class, orally-administered small-molecule medicine recently approved in China for the treatment of patients with anaemia from CKD on dialysis. Roxadustat (FG-4592) is an oral hypoxia … Important notice for users Veeva ID: Z4-25396Date of next review: August 2022. AstraZeneca PLC. “Annual Data Report.” 2017. OLYMPUS is one of two AstraZeneca-sponsored trials that are part of the global Phase III clinical trials programme. Overall safety findings are generally consistent with the NDD-CKD patient population. In the OLYMPUS trial, patients with moderate to severe CKD anemia (Hb <10.0 g/dL) were randomized 1:1 to receive 70 mg roxadustat or placebo 3 times a week. OLYMPUS is a Phase III, randomised, double-blinded, placebo-controlled trial designed to evaluate the efficacy and safety of roxadustat vs. placebo for the treatment of patients with anaemia in CKD stages 3, 4 and 5 whose disease progression is moderate to severe and who are non-dialysis dependent. In the US, according to the United States Renal Data System (USRDS), a majority of dialysis-eligible CKD patients are currently on dialysis. 2006 May;47(5):S1-S132. I have read this warning and will not be using any of the contained product information for clinical purposes. Cardiovascular, Renal & Metabolism (CVRM) together forms one of AstraZeneca’s three therapy areas and is a key growth driver for the Company. In the OLYMPUS trial (N=2781), roxadustat was associated with a statistically significant and clinically meaningful improvement in mean change from baseline in Hb levels, with a mean … Anaemia is particularly prevalent in patients with CKD, which affects more than 200 million people worldwide and is generally a progressive disease characterised by gradual loss of kidney function that may eventually lead to kidney failure. Pamrevlumab, an anti-CTGF human monoclonal antibody, is advancing towards Phase 3 clinical development for the treatment of idiopathic pulmonary fibrosis (IPF) and pancreatic cancer, and is currently in a Phase 2 trial for Duchenne muscular dystrophy (DMD). Data from the Phase III OLYMPUS and ROCKIES trials, together with the efficacy and pooled CV safety data from the global Phase III programme, will form part of the regulatory submission in the US, anticipated in Q4 2019. Roxadustat also improved Hb levels from baseline in a subgroup of patients with elevated hsCRP levels of greater than 5 mg/L, demonstrating a statistically significant improvement with a mean increase of 0.80g/dL compared to 0.59g/dL with epoetin alfa, a secondary endpoint. 2. Babitt JL, Lin HY. That is critical. We encourage you to read the privacy policy of every website you visit. Our country sites can be located in the AZ Network. OLYMPUS is a Phase III, randomised, double blind, placebo-controlled trial designed to evaluate the efficacy and safety of roxadustat vs. placebo for the treatment of NDD patients with … Top-line results announced in December 2018 showed ROCKIES met its primary efficacy endpoint. Roxadustat also improved Hb levels from baseline in a subgroup of patients with elevated high-sensitivity C-reactive protein (hsCRP) levels of greater than 5mg/L, with a statistically significant mean increase of 1.73 g/dL, compared to 0.62g/dL with placebo, a secondary endpoint. The Company’s ambition is to modify or halt the natural course of CVRM diseases and potentially regenerate organs and restore function, by continuing to deliver transformative science that improves treatment practices and cardiovascular health for millions of patients worldwide. We encourage you to read the privacy policy of every website you visit. AstraZeneca provides this link as a service to website visitors. “Annual Data Report.” 2017. [Online]. Veeva ID: Z4-25396Date of next review: August 2022. National Institute of Diabetes and Digestive and Kidney Diseases. Fibrogen has a lot riding on pivotal data for roxadustat, its project for anaemia in chronic kidney disease. Roxadustat, the company’s most advanced product candidate, is an oral small molecule inhibitor of HIF prolyl hydroxylase activity, completing worldwide Phase 3 clinical development for the treatment of anemia in chronic kidney disease (CKD), with a New Drug Application (NDA) now approved by the National Medical Products Administration (NMPA) in China. The HIMALYAYAS trial was a phase 3 study of the efficacy and safety of roxadustat in the treatment of anemia in incident dialysis patients. Methods: In this phase 3 trial conducted at 29 sites in China, we randomly assigned 154 patients with chronic kidney disease in a 2:1 ratio to receive roxadustat or placebo three times a week for 8 weeks … Clinicaltrials.gov. This website is intended for people seeking information on AstraZeneca's worldwide business. Roxadustat is in Phase 3 clinical development in the U.S. and Europe and in Phase 2/3 development in China for anemia associated with myelodysplastic syndromes (MDS). FibroGen, Inc., headquartered in San Francisco, California, with subsidiary offices in Beijing and Shanghai, People’s Republic of China, is a leading biopharmaceutical company discovering and developing a pipeline of first-in-class therapeutics. AstraZeneca operates in over 100 countries, and its innovative medicines are used by millions of patients worldwide. [Online]. Roxadustat for Treating Anemia in Patients with CKD Not on Dialysis: Results from a Randomized Phase 3 Study. Company Secretary Company Secretary 7. In the OLYMPUS trial, roxadustat demonstrated a statistically significant improvement in Hb levels from baseline, with a mean increase of 1.75g/dL averaged over weeks 28 to 52, compared to 0.40g/dL with placebo, the primary efficacy endpoint. FibroGen’s partner Astellas submitted an NDA for the treatment of anemia in CKD patients on dialysis in Japan in September 2018, currently under review by the Pharmaceuticals and Medical Devices Agency (PMDA). Click ‘cancel’ to return to AstraZeneca’s site or ‘continue’ to proceed. AstraZeneca provides this link as a service to website visitors. J Am Soc Nephrol (2012); 23:1631-1634. For more information, please visit www.fibrogen.com. Roxadustat Significantly Increased Hemoglobin Levels for Chronic Kidney Disease Patients with Anemia in Phase III OLYMPUS and ROCKIES Trials: Sep 26, 2019: FibroGen Announces Initiation of Phase 2 Clinical Trial of Roxadustat … FibroGen and Astellas anticipate reporting high-level results from their remaining trials in due course. AstraZeneca is not responsible for the privacy policy of any third party websites. 5. Please refer to your approved national product label (SmPC) for current product information. “Anaemia in Chronic Kidney Disease.” 2014. OLYMPUS: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, International Study of Roxadustat Efficacy in Patients with Non-Dialysis-Dependent (NDD) Chronic Kidney … OLYMPUS is a Phase III, randomised, double blind, placebo-controlled trial designed to evaluate the efficacy and safety of roxadustat vs. placebo for the treatment of NDD patients with anaemia from CKD stages 3, 4 and 5 . 3. Anaemia can be a serious medical condition in which patients have insufficient red blood cells and low levels of haemoglobin, a protein in red blood cells that carries oxygen to cells throughout the body.1,2 Anaemia from CKD is associated with increased risk of hospitalisation, CV complications and death,3 also frequently causing significant fatigue, cognitive dysfunction and decreased quality of life.4 Severe anaemia is common in patients with CKD, cancer, myelodysplastic syndrome, inflammatory diseases and other serious illnesses. Safety and Efficacy Study of Roxadustat to Treat Anemia in Patients With Chronic Kidney Disease (CKD), Not on Dialysis. You are about to access AstraZeneca historic archive material. I have read this warning and will not be using any of the contained product information for clinical purposes. Babitt JL, Lin HY. FibroGen, Inc., (FibroGen) and AstraZeneca are collaborating on the development and commercialisation of roxadustat for the treatment of anaemia in patients with CKD in the US, China, and other global markets. Am J Kidney Dis. Patients who experience chronic inflammation are often more difficult to treat than the overall chronic kidney disease patient population, emphasising the need for new treatment options.”. Roxadustat is a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) that promotes erythropoiesis by increasing endogenous production of erythropoietin and improving iron regulation and overcoming the negative impact of inflammation on haemoglobin synthesis and red blood cell production by downregulating hepcidin. In the OLYMPUS trial, roxadustat, given in 70 mg doses orally three times a week, demonstrated a statistically significant improvement in hemoglobin levels from baseline, with a mean … Anaemia is particularly prevalent in patients with CKD. In the OLYMPUS trial, the roxadustat group had slower progression of CKD compared with placebo. Additional serious adverse events reported were azotaemia, sepsis, acute kidney injury and hyperkalaemia. Important notice for users J Am Soc Nephrol. “Managing Anaemia When You Have Kidney Disease or Kidney Failure.” 2014. Sean Bohen, Executive Vice-President, Global Medicines Development and Chief Medical Officer, said: “These results add to the growing body of evidence for roxadustat, which is part of the largest clinical programme worldwide in evaluating the novel class of HIF-PHI. Oral iron was allowed; IV iron was used as standard of care (SoC) in the epoetin alfa arm and with evidence of iron deficiency in the roxadustat arm. You are about to access AstraZeneca historic archive material. In the OLYMPUS trial, researchers examined the efficacy of roxadustat for the treatment of anemia in patients with non-dialysis dependent chronic kidney disease (NDD CKD).
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