a3045u
FORM 6-K
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
Report
of Foreign Issuer
Pursuant
to Rule 13a-16 or 15d-16 of
the
Securities Exchange Act of 1934
For the
month of July 2020
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
Farxiga DAPA-CKD trial met all
endpoints
This announcement contains inside information
28 July 2020 07:00 BST
Farxiga met all primary and secondary endpoints in
groundbreaking Phase III DAPA-CKD trial for the treatment of
patients with chronic kidney disease
Farxiga significantly reduced the worsening
of renal function or risk of death
in patients with chronic kidney disease with and without type-2
diabetes
High-level results from Farxiga's (dapagliflozin) Phase III DAPA-CKD trial
showed a statistically significant and clinically meaningful
effect on its primary endpoint of a composite of worsening of
renal function or risk of death (defined as a composite endpoint of
≥50% sustained decline in estimated glomerular
filtration rate (eGFR), onset of end stage kidney disease (ESKD) or
cardiovascular (CV) or renal death) in adult patients with chronic
kidney disease (CKD). The trial also met all its secondary
endpoints in CKD patients with and without type-2 diabetes (T2D),
making Farxiga the first medicine to significantly reduce
the risk of death from any cause in this patient
population.
CKD is a serious, progressive condition
defined by decreased kidney function affecting nearly 700
million people worldwide,1,2 many
of them still undiagnosed.3,4 Currently
there are limited treatment options for these
patients.5 CKD
is associated with significant patient morbidity and an increased
risk of CV events,6 such
as heart failure (HF) and premature death.7
The co-chairs of the trial and its Executive Committee Prof. David
Wheeler, University College London, and Prof. Hiddo L. Heerspink,
University Medical Center Groningen, said: "The DAPA-CKD trial has
shown dapagliflozin's potential as a long-awaited new treatment
option for patients with chronic kidney disease. The data will be
transformative for these patients."
Mene Pangalos, Executive Vice President, BioPharmaceuticals
R&D, said: "DAPA-CKD is the first trial to demonstrate
overwhelming efficacy, including improvement on survival, in
chronic kidney disease patients both with and without type-2
diabetes. We look forward to sharing these
exciting Farxiga results with the scientific community
and health authorities
worldwide."
The safety and tolerability profile for Farxiga was consistent with the well-established
safety profile of the medicine.
The full DAPA-CKD trial results will be submitted for presentation
at a forthcoming medical meeting.
In March
2020, AstraZeneca announced
that the DAPA-CKD trial was being stopped early following a
recommendation from an independent Data Monitoring Committee based
on its determination of overwhelming efficacy.
Additionally, in May
2020, Farxiga was approved in the US to reduce the risk of
CV death and hospitalisation for heart failure (hHF) in adults with
HF (NYHA class II-IV) with reduced ejection fraction (HFrEF) with
and without T2D. Farxiga is also under review with the European
Medicines Agency, as well as in other regions, for the treatment of
patients with HF.
Chronic kidney disease
CKD can be a serious, progressive condition defined by decreased
kidney function (shown by reduced eGFR or markers of kidney damage,
or both, for at least three months).1 The
most common causes of CKD are diabetes, hypertension and
glomerulonephritis.8 In
its most severe form, known as ESKD, kidney damage and
deterioration of kidney function have progressed to the stage where
dialysis or kidney transplantation are required.9 The
majority of patients with CKD will die from CV causes before
reaching ESKD.10
DAPA-CKD
DAPA-CKD is an international, multi-centre, randomised,
double-blinded trial in 4,304 patients designed to evaluate the
efficacy of Farxiga 10mg, compared with placebo, in patients
with CKD Stages 2-4 and elevated urinary albumin excretion, with
and without T2D. Farxiga is given once daily in addition to standard
of care. The primary composite endpoint is worsening of renal
function or risk of death (defined as a composite of an eGFR
decline ≥50%, onset of ESKD and death from CV or renal
cause). The secondary endpoints included the time to first
occurrence of the renal composite (sustained ≥50% eGFR
decline, ESKD and renal death), the composite of CV death or hHF,
and death from any cause. The trial was conducted in 21
countries.
Farxiga
Farxiga (dapagliflozin) is
a first-in-class, oral, once-daily sodium-glucose co-transporter-2
(SGLT2) 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 HF or CV death versus placebo, when added to
standard of care.
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.
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 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.
AstraZeneca
AstraZeneca (LSE/STO/NYSE: 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 and
follow the Company on Twitter @AstraZeneca.
Contacts
For details on how to contact the Investor Relations Team, please
click here.
For Media contacts, click here.
References
1. Kidney Disease: Improving Global
Outcomes (KDIGO) CKD Work Group. KDIGO 2012 clinical practice
guideline for the evaluation and management of chronic kidney
disease. Kidney International
Supplement 2013;
(3):1-150.
2. GBD 2017 Global, regional, and
national incidence, prevalence, and years lived with disability for
354 diseases and injuries for 195 countries and territories,
1990-2017: asystematic analysis for the Global Burden of Disease
Study 2017 Lancet 2018; 392:1789-858.
3. National Kidney
Foundation. Kidney Disease: The Basics [cited 07.08.20]. Available from:
URL: https://www.kidney.org/news/newsroom/factsheets/KidneyDiseaseBasics.
4. Hirst
JA et al. Prevalence of chronic kidney disease in the community
using data from OxRen: A UK population-based cohort
study. Br J Gen
Pract 2020;
70(693):e285-e293.
5.
Ward F et al. Drug therapies to delay the progression of chronic
kidney disease. Clin Med (Lond) 2015; 15(6):550-7
6.
Bikbov, Boris, et al. "Global, Regional, and National Burden of
Chronic Kidney Disease, 1990-2017: a Systematic Analysis for the
Global Burden of Disease Study 2017." The Lancet, vol. 395, no.
10225, 13 Feb. 2020, pp. 709-733.,
doi:10.1016/s0140-6736(20)30045-3.
7.
Segall L et al. Heart failure in patients with chronic kidney
disease: A systematic integrative review. Biomed Res Int 2014;
2014:937398.
8. National Kidney
Foundation. Kidney Disease: Causes, 2017; [cited 2020 Jun 25].
Available from URL: https://www.kidney.org/atoz/content/kidneydiscauses
9. Centers for
Disease Control and Prevention. Chronic Kidney Disease in the
United States, 2019 [cited 01.05.20]. Available from
URL: https://www.cdc.gov/kidneydisease/publications-resources/2019-national-facts.html.
10. Briasoulis A, Bakris GL. Chronic Kidney
Disease as a Coronary Artery Disease Risk
Equivalent. Cur Cardiol
Rep 2013;
15(3):340.
Adrian Kemp
Company Secretary
AstraZeneca PLC
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized.
Date:
28 July 2020
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By: /s/
Adrian Kemp
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|
Name:
Adrian Kemp
|
|
Title:
Company Secretary
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