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  • AstraZeneca to present pivotal roxadustat Phase III data at the American Society of Nephrology Kidney Week 2019

AstraZeneca to present pivotal roxadustat Phase III data at the American Society of Nephrology Kidney Week 2019

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Pooled efficacy and cardiovascular safety analyses from global Phase III programme, and efficacy data from Phase III OLYMPUS and ROCKIES trials to be presented

Unprecedented 41 abstracts from the AstraZeneca renal portfolio and pipeline demonstrate commitment to advancing care

AstraZeneca will present pooled efficacy and cardiovascular safety analyses from the Phase III clinical programme of roxadustat for the treatment of anaemia from chronic kidney disease (CKD) in non dialysis-dependent (NDD) or dialysis-dependent (DD) patients.

The data are among an unprecedented 41 AstraZeneca abstracts including three late-breaking abstracts, accepted for oral and poster presentation at the American Society of Nephrology (ASN) Kidney Week 2019, which takes place from 5-10 November 2019 in Washington, DC, US.

The pooled efficacy and safety analyses add to the growing body of evidence on roxadustat, a novel hypoxia-inducible factor prolyl hydroxylase inhibitor. Additionally, analyses of the efficacy endpoints from the roxadustat Phase III OLYMPUS and ROCKIES trials for anaemia in CKD-NDD or CKD-DD patients, respectively, will be included in oral presentations.

Joris Silon, Senior Vice President, CVRM, BioPharmaceuticals Business Unit, said: “The unprecedented number of abstracts being presented by AstraZeneca at ASN 2019 demonstrates our commitment to advancing the care of chronic kidney disease and its complications, which affect millions of patients worldwide. We are applying our clinical and medical expertise in cardiovascular, renal and metabolism to generate new insights in chronic kidney disease that will make a real difference to patients.”

At the meeting, AstraZeneca will also present analyses from the landmark Phase III DAPA-HF trial, the first outcomes trial with a SGLT2 inhibitor assessing the treatment of heart failure in patients with reduced ejection fraction, with and without type-2 diabetes (T2D). Additional data from the Phase III DECLARE-TIMI 58 trial will also be presented, showing the effect of Farxiga on renal disease progression in patients with T2D.

For Lokelma (sodium zirconium cyclosilicate), a post-hoc analysis evaluating potassium balance from the Phase IIIb DIALIZE trial will show efficacy and safety data of the medicine in patients with hyperkalaemia on haemodialysis.

Notable AstraZeneca abstracts at ASN 2019 include:

Lead author Abstract title Presentation details
Fishbane, S ROCKIES: An International, Phase 3, Randomized, Open-Label, Active-Controlled Study of Roxadustat for Anemia in Dialysis-Dependent CKD Patients Oral Presentation #TH-OR022 Thursday 7 November 16:42-16:54 Session Room 150
Fishbane, S OLYMPUS: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, International Study of Roxadustat Efficacy in Patients with Non-Dialysis-Dependent (NDD) Chronic Kidney Disease (CKD) and Anemia Oral Presentation #TH-OR023 Thursday 7 November 16:54-17:06 Session Room 150
Provenzano, R / Fishbane, S. Pooled Efficacy and CV Safety of Roxadustat vs Placebo in NDD-CKD Patients and Epoetin Alfa in DD-CKD Patients Late-Breaking Session #FR-OR131 Friday 8 November 14:00-14:15 Ballroom C
Mosenzon, O Prevention of chronic kidney disease with dapagliflozin: analysis of the DECLARE-TIMI 58 trial Late-Breaking Poster
Thursday 7 November 10:00-12:00 Poster Hall
Solomon, SD The Dapagliflozin in Heart Failure with Reduced Ejection Fraction trial (DAPA-HF): Outcomes in patients with CKD and effects on renal function Late-Breaking Session #FR-OR133 Friday 8 November 14:30-14:45 Ballroom C
Fishbane, S Sodium Zirconium Cyclosilicate Improves Potassium Balance in Hyperkalemic Hemodialysis Patients: Results from the Phase 3b, Randomized, Placebo Controlled DIALIZE Study Oral Presentation #SA-OR061 Saturday 9 November 17:06-17:18 Session Room 144
Heerspink, HJL SAPPHIRE: Rationale and Design of a Phase 2b Study of Verinurad plus Allopurinol in Patients with Chronic Kidney Disease and Hyperuricemia Poster #INFO12-SA Saturday 9 November 10:00-12:00 Poster Hall
Stack, AG CITRINE: Verinurad Plus Febuxostat Rapidly Reduces Albuminuria in Type 2 Diabetes Independent of Pre-existing Kidney Disease Oral Presentation #SA-OR086 Saturday 9 November 18:06-18:18 Ballroom C
Complications of CKD
Palaka, E Understanding Patient Perspectives of the Impact, Awareness, and Treatment of Chronic Kidney Disease (CKD) Anemia: A US Patient Survey Poster #SA-PO232 Saturday 9 November 10:00-12:00 Poster Hall
Hao, C Understanding Patient Perspectives of the Impact and Treatment of CKD Anemia: A Patient Survey in China Poster #SA-PO233 Saturday 9 November 10:00-12:00 Poster Hall
Karaboyas, A Hyperkalemia Excursions and Mortality in Hemodialysis Patients: Results from the DOPPS Oral Presentation #SA-OR067 Saturday 9 November 18:18-18:30
Session Room 144

For a complete list of AstraZeneca data presentations during Kidney Week 2019, please access the ASN website.

About AstraZeneca in CVRM

Cardiovascular, Renal & Metabolism (CVRM) together forms one of AstraZeneca’s three therapy areas and is a key growth driver for the Company. 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. 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.

About AstraZeneca

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 and Metabolism, and Respiratory. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on Twitter @AstraZeneca.

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