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AstraZeneca to Present Pivotal Roxadustat Phase III Data at the American Society of Nephrology Kidney Week 2019

October 30, 2019 GMT

WILMINGTON, Del.--(BUSINESS WIRE)--Oct 30, 2019--

AstraZeneca will present pooled efficacy and cardiovascular safety analyses from the Phase III clinical program of roxadustat for the treatment of anemia 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-breakers, accepted for oral and poster presentation at the American Society of Nephrology (ASN) Kidney Week 2019, which takes place from November 5 to November 10 in Washington, D.C.

The pooled efficacy and safety analyses add to the growing body of evidence on roxadustat, an investigational hypoxia-inducible factor prolyl hydroxylase inhibitor. Additionally, analyses of the efficacy endpoints from the roxadustat Phase III OLYMPUS and ROCKIES trials for anemia 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 hyperkalemia on hemodialysis.

Notable AstraZeneca abstracts at ASN 2019 include:

Lead Author

Abstract Title

Presentation details

Roxadustat

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, November 7
4:42-4:54
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, November 7
4:54-5:06
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, November 8
2:00-2:15

Ballroom C

FARXIGA

Mosenzon, O

Chronic kidney disease with dapagliflozin: analysis of
the DECLARE-TIMI 58 trial

Late-Breaking Poster
#TH-PO1205
Thursday, November 7
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, November 8
2:30-2:45

Ballroom C

LOKELMA

Fishbane, S

Sodium Zirconium Cyclosilicate and Potassium
Balance in Hyperkalemic Hemodialysis Patients:
Results from the Phase 3b, Randomized, Placebo
Controlled DIALIZE Study

Oral Presentation
#SA-OR061
Saturday, November 9
5:06-5:18
Session Room 144

Verinurad

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, November 9
10:00-12:00
Poster Hall

Stack, AG

CITIRINE: Verinurad Plus Febuxostat Effect on
Albuminuria in Type 2 Diabetes Independent of
Pre-existing Kidney Disease

Oral Presentation
#SA-OR086
Saturday, November 9
6:06-6:18
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, November 9
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, November 9
10:00-12:00
Poster Hall

Karaboyas, A

Hyperkalemia Excursions and Mortality in
Hemodialysis Patients: Results from the DOPPS

Oral Presentation
#SA-OR067
Saturday, November 9
6:18-6:30
Session Room 144

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

Indication and Limitations of Use for FARXIGA ® (dapagliflozin) tablets

FARXIGA is indicated:

FARXIGA is not recommended for patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.

Important Safety Information for FARXIGA ® (dapagliflozin) tablets

Contraindications

Warnings and Precautions

Increases in serum creatinine and decreases in eGFR may be observed with initiation of FARXIGA. Elderly patients and patients with impaired renal function may be more susceptible to these changes. Consider temporarily discontinuing in settings of reduced oral intake or fluid losses

Before initiating FARXIGA, evaluate renal function and monitor periodically. FARXIGA is not recommended when the eGFR is <45 mL/min/1.73 m 2

Adverse Reactions
In a pool of 12 placebo-controlled studies, the most common adverse reactions (≥5%) associated with FARXIGA 5 mg, 10 mg, and placebo respectively were female genital mycotic infections (8.4% vs 6.9% vs 1.5%), nasopharyngitis (6.6% vs 6.3% vs 6.2%), and urinary tract infections (5.7% vs 4.3% vs 3.7%).

Use in Specific Populations

Please see accompanying USFull Prescribing InformationandMedication Guidefor FARXIGA.

IMPORTANT SAFETY INFORMATION FOR LOKELMA™ (sodium zirconium cyclosilicate) 10 g FOR ORAL SUSPENSION

WARNINGS AND PRECAUTIONS:

ADVERSE REACTIONS: The most common adverse reaction with LOKELMA was mild to moderate edema. In placebo-controlled trials up to 28 days, edema was reported in 4.4%, 5.9%, 16.1% of patients treated with 5 g, 10 g and 15 g of LOKELMA once daily, respectively vs 2.4% of patients receiving placebo.

DRUG INTERACTIONS: LOKELMA can transiently increase gastric pH. In general, oral medications with pH-dependent solubility should be administered at least 2 hours before or 2 hours after LOKELMA. Spacing is not needed if it has been determined the concomitant medication does not exhibit pH-dependent solubility.

INDICATION AND LIMITATION OF USE
LOKELMA is indicated for the treatment of hyperkalemia in adults.

LOKELMA should not be used as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of action.

PLEASE READ FULL PRESCRIBING INFORMATION.

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 commercialization of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, Cardiovascular, Renal & Metabolism and Respiratory. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information, please visit www.astrazeneca-us.com and follow us on Twitter @AstraZenecaUS.

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SOURCE: AstraZeneca

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PUB: 10/30/2019 07:00 AM/DISC: 10/30/2019 07:01 AM

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