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 September 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 reduces CKD
progression and risk of death
1 September 2020 07:00 BST
Farxiga demonstrated unprecedented reduction in the
risk of kidney failure and cardiovascular or renal death in
patients with chronic kidney disease in the Phase III DAPA-CKD
trial
Farxiga is the first medicine to significantly prolong survival in
a renal outcomes trial in patients with chronic kidney disease with
and without type-2 diabetes
Detailed results from the ground-breaking Phase III DAPA-CKD trial
showed that AstraZeneca's Farxiga (dapagliflozin) on top of standard of care
reduced the composite measure of worsening of renal
function or risk of cardiovascular (CV) or renal death by
39% compared to placebo (p<0.0001) in patients with chronic
kidney disease (CKD) Stages 2-4 and elevated urinary albumin
excretion. The results were consistent in patients both with
and without type-2 diabetes (T2D). 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 and
the most common causes are diabetes, hypertension and
glomerulonephritis.5
The primary composite endpoint was ≥50% sustained
decline in estimated glomerular filtration rate (eGFR), onset
of end-stage kidney disease (ESKD) and CV or renal death. The
absolute risk reduction (ARR) was 5.3% over the median time in
study of 2.4 years. The trial also met all secondary
endpoints, including significantly reducing death from any cause by
31% (ARR = 2.1%, p=0.0035) compared to placebo.
The co-chairs of the DAPA-CKD trial and its Executive Committee
Prof. David Wheeler, University College London, UK and Prof. Hiddo
L. Heerspink, University Medical Center Groningen, the Netherlands,
said: "The impressive DAPA-CKD trial results are a remarkable
development for patients with chronic kidney disease. These data
have the potential to transform the standard of care for this
patient population, which has a significant unmet need for new and
improved treatment options."
Mene Pangalos, Executive Vice President, BioPharmaceuticals
R&D, said: "With today's results, Farxiga becomes the first SGLT2 inhibitor proven to
significantly prolong the survival of patients with chronic kidney
disease with and without type-2 diabetes and we look forward to
sharing these data with regulatory authorities around the
world. Farxiga is also the first medicine in its class to
demonstrate benefit in treating both heart failure and chronic
kidney disease in patients with and without type-2 diabetes, and
reduce the risk of hospitalisation for heart failure and
nephropathy in type-2 diabetes."
The safety and tolerability of Farxiga were consistent with the well-established
safety profile of the medicine. In the trial, patients treated
with Farxiga experienced fewer serious adverse events
compared to placebo (29.5% versus 33.9%, respectively). Diabetic
ketoacidosis was not reported in the Farxiga group versus in two patients in the placebo
group.
Detailed results from the DAPA-CKD trial were presented on
Sunday 30 August at the ESC Congress 2020 - The Digital
Experience.
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
heart failure (NYHA class II-IV) with reduced ejection fraction
(HFrEF) with and without T2D. Farxiga is currently being assessed in patients with
heart failure (HF) in the DELIVER (HF with preserved ejection
fraction, HFpEF) and DETERMINE (HFrEF and HFpEF) trials, as well as
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.
Chronic kidney disease
CKD is 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) affecting nearly
700 million people worldwide, many of them still
undiagnosed.1-4 The
most common causes of CKD are diabetes, hypertension and
glomerulonephritis.5 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.6 The
majority of patients with CKD will die from CV causes before
reaching ESKD.7
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
and high-level results were announced in July
2020.
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 hHF or CV death versus placebo, when added to standard of
care. 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. Bikbov B 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 2020; 395(10225):709-33.
3. 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.
4. National Kidney
Foundation. Kidney Disease: The Basics; 2020 [cited 2020 Jun 29].
Available from: URL: https://www.kidney.org/news/newsroom/factsheets/KidneyDiseaseBasics.
5. National Kidney
Foundation. Kidney Disease: Causes, 2017; [cited 2020 Jun 25].
Available from URL: https://www.kidney.org/atoz/content/kidneydiscauses
6. 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.
7. 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:
01 September 2020
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By: /s/
Adrian Kemp
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|
Name:
Adrian Kemp
|
|
Title:
Company Secretary
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