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

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
Roxadustat
Fishbane, S ROCKIES: An Oral Presentation #TH-OR022 Thursday 7
International, November 16:42-16:54 Session Room 150
Phase 3,
Randomized,
Open-Label,
Active
-Controlled
Study of
Roxadustat for
Anemia in
Dialysis
-Dependent CKD
Patients
Fishbane, S OLYMPUS: A Oral Presentation #TH-OR023 Thursday 7
Phase 3, November 16:54-17:06 Session Room 150
Randomized,
Double-Blind,
Placebo
-Controlled,
International
Study of
Roxadustat
Efficacy in
Patients with
Non-Dialysis
-Dependent
(NDD) Chronic
Kidney Disease
(CKD) and
Anemia
Provenzano, R Pooled Late-Breaking Session #FR-OR131 Friday
/ Fishbane, S. Efficacy and 8 November 14:00-14:15 Ballroom C
CV Safety of
Roxadustat vs
Placebo in NDD
-CKD Patients
and Epoetin
Alfa in DD-CKD
Patients
Farxiga
Mosenzon, O Prevention of Late-Breaking Poster
chronic kidney #TH-PO1205 Thursday 7 November 10:00
disease with -12:00 Poster Hall
dapagliflozin:
analysis of
the DECLARE
-TIMI 58 trial
Solomon, SD The Late-Breaking Session #FR-OR133 Friday
Dapagliflozin 8 November 14:30-14:45 Ballroom C
in Heart
Failure with
Reduced
Ejection
Fraction trial
(DAPA-HF):
Outcomes in
patients with
CKD and
effects on
renal function
Lokelma
Fishbane, S Sodium Oral Presentation #SA-OR061 Saturday 9
Zirconium November 17:06-17:18 Session Room 144
Cyclosilicate
Improves
Potassium
Balance in
Hyperkalemic
Hemodialysis
Patients:
Results from
the Phase 3b,
Randomized,
Placebo
Controlled
DIALIZE Study
Verinurad
Heerspink, HJL SAPPHIRE: Poster #INFO12-SA Saturday 9 November
Rationale and 10:00-12:00 Poster Hall
Design of a
Phase 2b Study
of Verinurad
plus
Allopurinol in
Patients with
Chronic Kidney
Disease and
Hyperuricemia
Stack, AG CITRINE: Oral Presentation #SA-OR086 Saturday 9
Verinurad Plus November 18:06-18:18 Ballroom C
Febuxostat
Rapidly
Reduces
Albuminuria in
Type 2
Diabetes
Independent of
Pre-existing
Kidney Disease
Complications
of CKD
Palaka, E Understanding Poster #SA-PO232 Saturday 9 November
Patient 10:00-12:00 Poster Hall
Perspectives
of the Impact,
Awareness, and
Treatment of
Chronic Kidney
Disease (CKD)
Anemia: A US
Patient Survey
Hao, C Understanding Poster #SA-PO233 Saturday 9 November
Patient 10:00-12:00 Poster Hall
Perspectives
of the Impact
and Treatment
of CKD Anemia:
A Patient
Survey in
China
Karaboyas, A Hyperkalemia Oral Presentation #SA-OR067 Saturday 9
Excursions and November 18:18-18:30
Mortality in Session Room 144
Hemodialysis
Patients:
Results from
the DOPPS

For a complete list of AstraZeneca data presentations during Kidney Week 2019, please access the ASN website (https://www.asn-online.org/education/kidneyweek/2019/program-search-abstract.aspx).

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 (http://www.astrazeneca.com/) and follow the Company on Twitter @AstraZeneca (https://twitter.com/AstraZeneca).

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