AstraZeneca will present 84 abstracts, including 12 oral presentations and three late-breaking abstracts, across its industry-leading renal portfolio which includes roxadustat, Farxiga (dapagliflozin) and Lokelma (sodium zirconium cyclosilicate), at ASN Kidney Week 2020 Reimagined, taking place virtually from 22-25 October 2020.

The data advance AstraZeneca's ambition to create a coordinated pathway for renal patients to advance earlier diagnosis and help prevent or slow the progression of chronic kidney disease (CKD) and address its life-threatening complications, such as anaemia and hyperkalaemia.[1,2 ]

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: "The breadth of data being presented by AstraZeneca demonstrates the growing momentum of our renal portfolio. Our ambition is to provide new treatments for hundreds of millions of patients with chronic kidney disease, a progressive condition for which there currently is no cure. We are particularly excited to share insights into the safety and efficacy of roxadustat in anaemia of chronic kidney disease and new subgroup data from the DAPA-CKD trial looking at the benefit of Farxiga regardless of disease cause."

Roxadustat - redefining the management of anaemia of CKD

• Late-breaking presentations of pooled analyses of Phase III trials[ ]investigating the association between haemoglobin levels and CV outcomes in dialysis-dependent (DD) and non-dialysis dependent (NDD)-CKD patients. Cardiovascular (CV) outcomes are common and serious complications in patients with CKD.[3-5]
• An oral presentation exploring whether roxadustat can reduce the risk of hospitalisation for heart failure, a common comorbidity in patients with CKD.[6]
• Analyses of whether roxadustat has the potential to reduce the risk of red blood cell (RBC) transfusions, a treatment for anaemia associated with additional complications, in both DD-CKD and NDD-CKD patients.[7]

• An analysis exploring the effect of roxadustat on achieving haemoglobin levels ≥10 g/dL in patients with NDD-CKD.[8]

• New data from pooled analyses of Phase III trials on DD-CKD patient subgroups, including those who are receiving peritoneal dialysis and are new to dialysis.[9,10]

Farxiga - setting a new standard in early CKD protection

New late-breaking subgroup data from the ground-breaking DAPA-CKD Phase III trial evaluating the potential benefit of Farxiga in patients with CKD irrespective of the underlying cause.[11 ]Detailed results presented in August (https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2020/farxiga-demonstrated-reduction-in-the-risk-of-kidney-failure-and-cardiovascular-or-renal-death-in-patients-with-ckd-in-the-phase-iii-dapa-ckd-trial.html) and published (https://www.nejm.org/doi/full/10.1056/NEJMoa2024816?query=main_nav_lg) in The New England Journal of Medicine established Farxiga as the first medicine to significantly prolong survival in a renal outcomes trial in patients with CKD with and without type-2 diabetes (T2D).

Lokelma - advancing proactive potassium management

New sub-analyses of the DIALIZE Phase IIIb trial and real-world evidence in patients living with CKD and hyperkalaemia demonstrate the potential of Lokelma as an option for hyperkalaemia management.[12-14] Hyperkalaemia is a common complication in patients with CKD and can result in serious arrhythmias, sudden cardiac arrest, paralysis and weakness, and even death.[2,15,16] If not managed effectively, complications like hyperkalaemia can impact ongoing treatment approaches, leading to life-saving treatments being reduced or discontinued.[16]

Uncovering the unique unmet needs of the CKD patient community

AstraZeneca will also present new insights into patients' experiences living with CKD as well as actionable gaps in treatment and management. New data will be presented from DISCOVER-CKD, a trial that assesses current real-world practice patterns and clinical management of patients with CKD. It reveals the burden of disease and factors that determine poor clinical outcomes, underscoring the need for improved treatment options.[17]

AstraZeneca key abstracts at ASN Kidney Week 2020 include:

Lead author Abstract title Presentation details
Roxadustat
Provenzano, Associations ePoster #PO262622 October
R. between Achieved
Hemoglobin and
Cardiovascular
Outcomes in the
Pooled Phase 3
Trials of
Roxadustat in
Dialysis
-dependent
Patients with
Anemia of Chronic
Kidney Disease
Fishbane, Associations ePoster #PO262522 October
S. between Achieved
Hemoglobin and
Cardiovascular
Outcomes in the
Pooled Phase 3
Trials of
Roxadustat in Non
-Dialysis
-dependent
Patients with
Anemia of Chronic
Kidney Disease
Provenzano, Roxadustat Oral Abstract #TH-OR03 22
R. Treatment of October 17:00 - 19:00 PM EDT
Anemia in Non
-Dialysis
-Dependent
Chronic Kidney
Disease is Not
Influenced by
Iron Status
Fishbane, Roxadustat Lowers ePoster #PO025622 October
S. Risk of RBC
Transfusion in
Patients with
Anemia in CKD
Pergola, Hemoglobin (Hb) Oral Abstract #TH-OR0622
P.E. correction with October 5:00 - 7:00 PM EDT
roxadustat is
associated with
improved iron
homeostasis in
patients with
dialysis
-dependent
chronic kidney
disease (DD-CKD)
El-Shahawy, Roxadustat ePoster #PO026522 October
M. Increases
Hemoglobin in
Anemic Dialysis
-Dependent (DD)
Chronic Kidney
Disease (CKD)
Patients
Independent of
Inflammation
Pecoits Roxadustat Oral Abstract #TH-OR0522
-Filho, R. treatment results October 17:00 - 19:00 PM EDT
in consistent
improvements in
hemoglobin (Hb)
versus placebo:
an analysis of 3
multinational
RCTs in patients
with non-dialysis
-dependent
chronic kidney
disease (NDD-CKD)
Rastogi, A. Roxadustat ePoster #PO0264 22 October
treatment
corrects anemia
to hemoglobin
(Hb) values ≥10
g/dL in the
majority of
patients with non
-dialysis
-dependent
chronic kidney
disease (NDD-CKD)
Pollock, Roxadustat ePoster #PO026322 October
C.A. Increases
Hemoglobin in
Anemic Non
-Dialysis
-Dependent (NDD)
Chronic Kidney
Disease (CKD)
Patients
Independent of
Inflammation
Provenzano, Pooled Analyses Oral Abstract #SA-OR3924
R. of the Phase 3 October 17:00 - 19:00 PM EDT
Roxadustat
Studies:
Congestive Heart
Failure
Hospitalization
Rates in Dialysis
and Non-Dialysis
Patients with
Anemia treated
with Roxadustat
versus
Comparators
Provenzano, Efficacy and Oral Abstract #FR-OR2523
R. Safety of October 17:00 - 19:00 PM EDT
Roxadustat in
Patients with
Dialysis
-dependent
Chronic Kidney
Disease and
Anemia on
Hemodialysis
Chan, T.M. Efficacy and Oral Abstract #SU-OR2425
Safety of October 17:00 - 19:00 PM EDT
Roxadustat in
Patients with
Dialysis
-dependent
Chronic Kidney
Disease and
Anemia on
Peritoneal
Dialysis
Lopes, M. A Real World Oral Abstract #TH-OR1022
Longitudinal October17:00 - 19:00 PM EDT
Analysis of
Anemia Treatment
Prescriptions in
Non-Dialysis
-Dependent
Chronic Kidney
Disease Patients,
a CKDopps Study
Barratt, J. Roxadustat for Oral Abstract #TH-OR0222
the Treatment of October 17:00 - 19:00 PM EDT
Anemia in Chronic
Kidney Disease
(CKD) Patients
Not on Dialysis
(NDD): A Phase 3,
Randomized, Open
-Label, Active
-Controlled Study
Provenzano, Adverse Event Oral Abstract #TH-OR0922
R. Rates are Higher October 17:00 - 19:00 PM EDT
Post-transfusion
vs. Overall
Follow-up and
Independent of
Background Anemia
Treatment in
Patients with
Chronic Kidney
Disease
Coyne, D.W. Roxadustat Is Not Oral Abstract #TH-OR0422
Associated with October 17:00 - 19:00 PM EDT
An Increased Risk
of Neoplasm in
Patients with
Chronic Kidney
Disease and
Anemia
Provenzano, Subgroup Analyses ePoster #PO0260  22 October
R. of Efficacy of
Roxadustat for
Treatment of
Anemia in
Patients with
Incident-Dialysis
-dependent
Chronic Kidney
Disease
Farxiga
Wheeler, Effects of Oral Abstract #FR-OR5823
D.C. dapagliflozin on October 10:30 AM - 12:30 PM
kidney function, EDT
cardiovascular
events and all
-cause mortality
according to
cause of kidney
disease in the
DAPA-CKD trial
Heerspink, Effects of the ePoster #PO058822 October
H.J.L. SGLT2 Inhibitor
Dapagliflozin on
Proteinuria in
Non-Diabetic
Patients with
Chronic Kidney
Disease
(DIAMOND): A
Randomized Double
-Blind Cross-Over
Trial
McEwan, P. The impact of ePoster #PO058922 October
decline in renal
function on the
clinical and
economic burden
of chronic kidney
disease: an
application of
the DAPA-CKD cost
-effectiveness
model
Birkeland, Lower Cardiorenal ePoster #PO095422 October
K.I. Risk with SGLT2i
versus DPP4i in
T2D Patients
without
Established
Cardiovascular-
and Renal
Diseases: A Large
Multinational
Observational
Study
Lokelma
Spinowitz, Disease course of ePoster #PO1165 22 October
B. hyperkalemia in
patients on
hemodialysis
Fishbane, Risk of ePoster #PO105122 October
S. Hypokalemia in
Hyperkalemic
Hemodialysis
Patients
Tafesse, E. Hyperkalaemia ePoster #PO0968 22 October
risk and
mortality in
patients with
diabetes
Tafesse, E. The relationship ePoster #PO145022 October
between chronic
kidney disease
duration, serum
potassium level
and adverse
outcomes
Tafesse, E. The relationship ePoster #PO144822 October
between
comorbidities and
hyperkalaemia in
patients with CKD
James, G. Patient ePoster #PO1456 22 October
palatability and
preference study
of 3 potassium
binders in
patients with
chronic kidney
disease and
hyperkalemia:
rationale and
design of the
APPETIZE study
Israni, R. Patient and ePoster #PO1455 22 October
Clinician
Preferences for
Hyperkalemia
Treatment: A
Qualitative Study
Hsuing, Time to ePoster #PO2054 22 October
J.T. Hyperkalemia
Recurrence in One
Year among
103,155 US
Veterans
Kanda, E. Performance of ePoster #PO145322 October
machine learning
models for risk
prediction of
adverse events in
hyperkalemic
patients
Davis, J. Post-discharge ePoster #PO144522 October
outcomes among
hyperkalemic
patients treated
with and without
SPS in the
inpatient setting
Perez Prevalence and ePoster #PO0479 22 October
-Navarro, severity of
L.M. hyperkalemia in
patients referred
to nephrology
consultation.
Epidemiologic
data from 1106
Mexican patients
at a national
reference
hospital.
DISCOVER
-CKD
Wittbrodt, Baseline ePoster #PO0486 22 October
E. characteristics
of non-dialysis
CKD patients with
and without
anemia: a report
from the
retrospective
cohort from
DISCOVER CKD
Wittbrodt, Treatment ePoster #PO028722 October
E. pathways of non
-dialysis
dependent CKD
patients with
anemia: A report
from the DISCOVER
CKD retrospective
cohort
Garcia Healthcare ePoster #PO049822 October
-Sanchez, resource
J.J. utilisation and
costs of chronic
kidney disease
according to the
2012 KDIGO CKD
classification: A
Report from the
DISCOVER CKD
Retrospective
Cohort
Cotadutide
Parker, Efficacy and ePoster #PO101822 October
V.E.R. safety of
cotadutide, a
dual GLP-1 and
glucagon receptor
agonist, for
patients with
type 2 diabetes
mellitus and
chronic kidney
disease
General CKD
James, G. Development of a ePoster #PO057722 October
Global Chronic
Kidney Disease
-Personal Impact
Index (CKD-PII)
Assessing the
Reality of Living
with CKD
 

ASN Kidney Week 2020 abstracts are available online (https://www.asn-online.org/education/kidneyweek/2020/program-search-abstract.aspx).

Roxadustat

Roxadustat is a first-in-class oral small molecule hypoxia-inducible-factor prolyl hydroxylase inhibitor (HIF-PHI) that promotes erythropoiesis through increased endogenous production of erythropoietin; improved iron absorption, transport and mobilisation; and downregulation of hepcidin, which helps to overcome the negative impact of inflammation on haemoglobin synthesis and red blood cell production. Roxadustat is approved in China for the treatment of anaemia in adult patients with CKD, both on dialysis and not on dialysis. In Japan, roxadustat is approved for the treatment of anaemia in CKD patients on dialysis, and a supplemental New Drug Application (NDA) for the treatment of anaemia in CKD patients not on dialysis is under regulatory review. The roxadustat NDA for the treatment of anaemia in CKD in both NDD and DD is under review by the US Food and Drug Administration with a decision expected in Q4 2020. The Marketing Authorisation Application for roxadustat for the treatment of anaemia in CKD in both NDD and DD was filed by Astellas and accepted by the European Medicines Agency for review on 21 May 2020. Roxadustat is also in clinical development for anaemia associated with myelodysplastic syndromes (MDS) and for chemotherapy-induced anaemia (CIA).

AstraZeneca and FibroGen Inc. (FibroGen) are collaborating on the development and commercialisation of roxadustat for the potential treatment of anaemia in the US, China and other markets in the Americas and in Australia/New Zealand, as well as Southeast Asia. Astellas and FibroGen are collaborating on the development and commercialisation of roxadustat for the potential treatment of anaemia in territories including Japan, Europe, the Commonwealth of Independent States, the Middle East and South Africa. At ASN Kidney Week 2020 Reimagined, roxadustat data will be sponsored and presented by Astellas, AstraZeneca and FibroGen.

Farxiga

Farxiga (dapagliflozin) is a first-in-class, oral, once-daily sodium-glucose co-transporter-2 inhibitor indicated in adults for the treatment of insufficiently controlled T2D as both monotherapy and as part of combination therapy as an adjunct to diet and exercise to improve glycaemic control, with the additional benefits of weight loss and blood-pressure reduction. In the DECLARE CV outcomes trial in adults with T2D, Farxiga reduced the risk of the composite endpoint of hospitalisation for heart failure (hHF) or CV death versus placebo, when added to standard of care.

In May 2020 (https://nam05.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.astrazeneca.com%2Fmedia-centre%2Fpress-releases%2F2020%2Ffarxiga-approved-in-the-us-for-the-treatment-of-heart-failure-in-patients-with-heart-failure-with-reduced-ejection-fraction.html&data=02%7C01%7CCelia.Rumbin%40edelman.com%7Cd54d0bba313c4631928f08d8699ed162%7Cb824bfb3918e43c2bb1cdcc1ba40a82b%7C0%7C1%7C637375478130038326&sdata=pZt2Rj%2FN2Q5gc8HQqTGf0rdwNkZ4rxJ6e%2FVEPsKvcpQ%3D&reserved=0), Farxiga was approved in the US to reduce the risk of CV death and hHF in adults with heart failure (HF) (NYHA class II-IV) with reduced ejection fraction (HFrEF) with and without T2D. In the DAPA-CKD Phase III trial in patients with CKD, Farxiga met all primary and secondary endpoints, providing overwhelming efficacy. Farxiga is currently being tested for patients with HF in the DELIVER (HF with preserved ejection fraction, HFpEF) and DETERMINE (HFrEF and HFpEF) trials. Farxiga will also be tested in patients without T2D following an acute myocardial infarction (MI) or heart attack in the DAPA-MI trial - a first of its kind, indication-seeking registry-based randomised controlled trial. Farxiga has a robust programme of clinical trials that includes more than 35 completed and ongoing Phase IIb/III trials in more than 35,000 patients, as well as more than 2.5 million patient-years' experience.

Lokelma  

Lokelma (sodium zirconium cyclosilicate) is an insoluble, non-absorbed sodium zirconium silicate, formulated as a powder for oral suspension, that acts as a highly selective potassium-removing medicine. It is administered orally, is odourless, tasteless and stable at room temperature. It has been studied in three double-blind, placebo-controlled trials and one 12-month open-label clinical trial in patients with hyperkalaemia.

AstraZeneca in CVRM

Cardiovascular, Renal and 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 comorbidities. 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.

AstraZeneca

AstraZeneca (LSE/STO/Nasdaq: AZN) 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 & Immunology. Based in Cambridge, UK, 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).

Contacts

For details on how to contact the Investor Relations Team, please click here (https://www.astrazeneca.com/investor-relations.html#Contacts). For Media contacts, click here (https://www.astrazeneca.com/media-centre/contacts.html).

References

1. KDOQI Clinical Practice Guidelines and Clinical Practice Recommendations for Anemia in Chronic Kidney Disease. Am J Kidney Dis 2006; 47(5 Suppl 3):S1-146.
2. National Kidney Foundation. Clinical Update on Hyperkalemia: A chronic Risk for CKD Patients and a Potential Barrier to Recommended CKD Treatment. New York: National Kidney Foundation; 2014 [cited 16 October 2020]. Available from: URL: https://www.kidney.org/sites/default/files/02-10-6785_HBE_Hyperkalemia_Bulletin.pdf.
3. Fishbane S et al. Associations between Achieved Hemoglobin and Cardiovascular Outcomes in the Pooled Phase 3 Trials of Roxadustat in Dialysis-dependent Patients with Anemia of Chronic Kidney Disease. Abstract #PO2625 presented at: American Society of Nephrology - Kidney Week 2020 Reimagined, 19-25 October 2020.
4. Provenzano R et al. Associations between Achieved Hemoglobin and Cardiovascular Outcomes in Phase 3 Roxadustat Studies of Non dialysis-dependent Patients with Anemia of Chronic Kidney Disease. Abstract # #PO2626 presented at: American Society of Nephrology - Kidney Week 2020 Reimagined, 19-25 October 2020.
5. Centers for Disease Control and Prevention (CDC). Chronic Kidney Disease: Common - Serious - Costly; 12 December 2019 [cited 16 October 2020]. Available from: URL: https://www.cdc.gov/kidneydisease/prevention-risk/CKD-common-serious-costly.html.
6. Provenzano R et al. Pooled Analyses of the Phase 3 Roxadustat Studies: Congestive Heart Failure Hospitalization Rates in Dialysis and Non-Dialysis Patients with Anemia treated with Roxadustat versus Comparators. Abstract #SA-OR39 presented at: American Society of Nephrology - Kidney Week 2020 Reimagined, 19-25 October 2020.
7. Fishbane S et al. Roxadustat Lowers Risk of RBC Transfusion in Patients with Anemia in CKD. Abstract #PO0256 presented at: American Society of Nephrology - Kidney Week 2020 Reimagined, 19-25 October 2020.
8. Rastogi, A et al. Roxadustat treatment corrects anemia to hemoglobin (Hb) values ≥10 g/dL in the majority of patients with non-dialysis-dependent chronic kidney disease (NDD-CKD). Abstract #PO0264 presented at: American Society of Nephrology - Kidney Week 2020 Reimagined, 19-25 October 2020.
9. Chan, TM et al. Efficacy and Safety of Roxadustat in Patients with Dialysis-dependent Chronic Kidney Disease and Anemia on Peritoneal Dialysis. Oral #SU-OR24 presented at: American Society of Nephrology - Kidney Week 2020 Reimagined, 19-25 October 2020.
10. Provenzano R et al. Subgroup Analyses of Efficacy of Roxadustat for Treatment of Anemia in Patients with Incident-Dialysis-dependent Chronic Kidney Disease Abstract #PO0259 presented at: American Society of Nephrology - Kidney Week 2020 Reimagined, 19-25 October 2020.
11. Wheeler D. Effects of dapagliflozin on kidney function, cardiovascular events and all-cause mortality according to cause of kidney disease in the DAPA-CKD trial. Abstract #FR-OR58 presented at: American Society of Nephrology - Kidney Week 2020 Reimagined, 19-25 October 2020.
12. Fishbane S. Risk of Hypokalemia in Hyperkalemic Hemodialysis Patients. Abstract #PO1051 presented at: American Society of Nephrology - Kidney Week 2020 Reimagined, 19-25 October 2020.
13. Tafesse E, James G, Sugrue D, Hurst M, Hoskin L, Badora K, McEwan P. The relationship between comorbidities and hyperkalaemia in patients with chronic kidney disease. Abstract #PO1448 presented at: American Society of Nephrology - Kidney Week 2020 Reimagined, 19-25 October 2020.
14. Tafesse E, James G, Hurst M, Hoskin L, Badora K, Sugrue D, McEwan P. The relationship between chronic kidney disease duration, serum potassium level and adverse outcomes. Abstract #PO1450 presented at: American Society of Nephrology - Kidney Week 2020 Reimagined, 19-25 October 2020.
15. American Heart Association. Part 10.1: Life-Threatening Electrolyte Abnormalities. Circulation 2005; 112(24_suppl):IV-121-IV-125.
16. Montford JR et al. How Dangerous is Hyperkalaemia? J Am Soc Nephrol. 2017 Nov;28(11):3155-3165.
17. U.S. National Institutes of Health. A Study on Patients With Chronic Kidney Disease (CKD) to Assess Treatment Experience and Patterns, Effect of the Treatment, Patient Outcomes and Patient Quality of Life (DISCOVER CKD) [Identifier: NCT04034992] [cited 16 October 2020]. Available from: URL: https://clinicaltrials.gov/ct2/show/NCT04034992.