Tags : Roxadustat

Astellas Reports Results of Roxadustat in P-III DOLOMITES Study to

Shots: The P-III study involves assessing of Roxadustat (N=323) vs darbepoetin alfa (N=293) evaluating its safety and efficacy in (N=616) adult anemia patients with stage 3–5 chronic kidney disease (CKD) The study meet its 1EPs & 2EPs also demonstrated superiority, showing correction of hemoglobin levels during the first 24 wks. (89.5% vs 78.0%), decrease in […]Read More

Astellas and FibroGen Report EMA’s Acceptance of MAA for Roxadustat

Shots: The MAA is supported by P-III program which includes 9000+ patients globally and data from DOLOMITES study, results of which will be disclosed this year. Results of P-III program demonstrated that the therapy is efficacious in increasing & maintaining target hemoglobin levels with reduction in the use of IV iron in patients with CKD […]Read More

Astellas Reports Submission of sNDA to MHLW for Evrenzo (roxadustat)

Shots: The sNDA is based on three studies in 500+ patients with NDD-CKD. The first P-III study involve assessing Evrenzo vs darbepoetin alfa resulted in meeting 1EPs of non-inferiority and maintenance of Hb levels over time and is well tolerated The other two studies (one P-II & one P-III) supported the safety and efficacy in […]Read More

ViewPoints Interview: AstraZeneca’s Global Medicine Leader John Houghton Shares Insights

AstraZeneca presented P-III data of Roxadustat along with unprecedented 41 abstracts from its renal portfolio at American Society of Nephrology Kidney Week 2019, demonstrating its commitment to advancing the care of Chronic Kidney Diseases (CKD) and its complications, affecting millions of people across the globe. On Nov 12, 2019 in an interview with PharmaShots, John […]Read More

AstraZeneca Reports Results of Roxadustat in P-III OLYMPUS and ROCKIES

Shots: The P-III OLYMPUS study involve assessing of Roxadustat vs PBO in 2,781 patients with anaemia (Hb<10.0g/dL) in a ratio (1:1) in non-dialysis-dependent -CKD stages, resulted in improvement in Hb levels (1.75g/dL vs 0.40g/dL) and improvement in Hb levels in patients with elevated hsCRP levels > 5mg/L (1.73 g/dL vs 0.62g/dL) The P-III ROCKIES study […]Read More

Astellas and FibroGen’s Evrenzo (roxadustat) Receives MHLW’s Approval for Anemia

Shots: The approval is based on four P-III studies evaluating Evrenzo (20/50/100mg) in CKD anemic patients on dialysis in Japan, demonstrating increment in hemoglobin level and is well tolerated among the patients, marking the first approval of the collaboration Astellas and FibroGen collaborated to develop Evrenzo for treating anemia in Japan, Europe, the Commonwealth of […]Read More

AstraZeneca and FibroGen’s Roxadustat Receive NMPA’s Approval for the Treatment

Shots: The NMPA’s approval is based on P-III study result assessing Roxadustat vs PBO in non-dialysis-dependent (NDD) patients with CKD demonstrating improvement in hemoglobin levels with a mean change of (1.9 g/dL vs -0.4 g/dL) on 7-9wks. treatment In 2013, AstraZeneca and FibroGen collaborated for the development & commercialization of Roxadustat in China. The NMPA’s […]Read More

AstraZeneca Reports Results of Roxadustat in Global Phase III Programme

Shots: The P-III global programme involves assessing of Roxadustat vs PBO & epoetin alfa in 9,000+ patients with anemia + CKD not on dialysis (NDD) , dialysis-dependent (DD), ID respectively Pooled analyses results: MACE/MACE+ in NDD & DD patients, clinically no difference; MACE/MACE+ in ID patients shows better results Roxadustat is hypoxia-inducible-factor prolyl hydroxylase inhibitor, […]Read More