a2398d
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 June 2021
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.
Forxiga recommended in EU for patients with
CKD
28 June 2021 07:05 BST
Forxiga recommended for approval in the EU by
CHMP
for the treatment of patients with chronic kidney
disease
If approved, Forxiga has the potential to change the treatment
paradigm
for millions of people in the EU suffering from chronic kidney
disease
AstraZeneca's Forxiga (dapagliflozin) has been recommended for
approval in the European Union (EU) for the treatment of
chronic kidney disease (CKD) in adults with and without type-2
diabetes (T2D).
The Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency based its positive opinion on results
from the DAPA-CKD Phase III trial that
showed Forxiga, on top of standard-of-care treatment with
an angiotensin-converting enzyme inhibitor or an angiotensin
receptor blocker, reduced the risk of the composite of worsening of
renal function, end-stage kidney disease (ESKD) and cardiovascular
(CV) or renal death, compared to placebo.
Forxiga also significantly
reduced the risk of death from any cause, compared to placebo. In
the trial, the safety and tolerability of Forxiga were consistent with the well-established
safety profile of the medicine.
CKD is a serious, progressive condition defined by decreased kidney
function and is often associated with an increased risk of heart
disease or stroke.1-3 It
affects approximately 47 million people in the EU and nearly 840
million people worldwide.3,4 However,
diagnosis rates remain low and up to 90% of patients are unaware
they have the disease.5
Mene Pangalos, Executive Vice President, BioPharmaceuticals
R&D, said: "The unprecedented results of the DAPA-CKD Phase III
trial show that Forxiga can significantly slow the decline of kidney
function and reduce the risk of death for patients with chronic
kidney disease. This positive CHMP opinion
underscores Forxiga's potential to transform the future care of
chronic kidney disease and brings us one step closer to providing a
much-needed new treatment option to millions of patients in the
EU."
Forxiga (known
as Farxiga in the US) was
recently approved in the
US for the treatment of
CKD in adults with and without T2D and, in addition to the EU,
is currently under review in Japan and other countries
around the world. Forxiga is
also indicated as an adjunct to diet and exercise to improve
glycaemic control in adults with T2D and for the treatment of
symptomatic chronic heart failure (HF) with reduced ejection
fraction (HFrEF) in adults with and without
T2D.
CKD
CKD is a serious,
progressive condition defined by decreased kidney function (shown
by reduced estimated glomerular filtration rate (eGFR) or markers
of kidney damage, or both, for at least three
months).3 The
most common causes of CKD are diabetes, hypertension and
glomerulonephritis.6 CKD
is associated with significant patient morbidity and an increased
risk of CV events, such as HF and premature death. In its
most severe form, known as ESKD, kidney damage and deterioration of
kidney function have progressed to the point where dialysis or
kidney transplantation are required.1 The
majority of patients with CKD will die from CV causes before
reaching ESKD.7
DAPA-CKD
DAPA-CKD was an international, multi-centre, randomised,
double-blinded Phase III trial in 4,304 patients designed to
evaluate the efficacy of Forxiga 10mg, compared with placebo, in patients
with CKD Stage 2-4 and elevated urinary albumin excretion, with and
without T2D. Forxiga was given once daily in addition to standard
of care. The primary composite endpoint was worsening of renal
function or risk of death (defined as a composite of an eGFR
decline ≥50%, onset of ESKD or death from CV or renal cause).
The secondary endpoints included the time to first occurrence of
the renal composite (sustained ≥50% eGFR decline, ESKD or
renal death), the composite of CV death or hospitalisation for
HF (hHF), and death from any cause. The trial was conducted in 21
countries.8 Detailed
results from the trial were published in The
New England Journal of Medicine.8
Forxiga
Forxiga (dapagliflozin) is
a first-in-class, oral, once-daily sodium-glucose cotransporter 2
(SGLT2) inhibitor. The research for Forxiga is advancing from cardiorenal effects to
prevention and organ protection as science continues to identify
the underlying links between the heart, kidneys and pancreas.
Damage to one of these organs can cause the other organs to fail,
contributing to leading causes of death worldwide, including T2D,
HF and CKD.
For nearly a decade Forxiga has been an effective monotherapy and part
of combination therapy as an adjunct to diet and exercise to
improve glycaemic control in adults with T2D. Following results
from the landmark DECLARE-TIMI 58 Phase III CV outcomes trial, it
is approved in adults with T2D to reduce the risk of hHF or CV
death when added to standard of care.9 Forxiga is
also the first SGLT2
inhibitor approved for the
treatment of HFrEF in adults with and without
T2D.
In August 2020, results from the
DAPA-CKD Phase III trial demonstrated that Forxiga achieved unprecedented reduction in the
composite risk of kidney failure and CV or renal death in patients
with CKD with and without T2D versus placebo.8 It
is now the first SGLT2
inhibitor approved for the
treatment of CKD regardless of diabetes status.
DapaCare is a robust programme of clinical trials to evaluate the
potential CV, renal and organ protection benefits
of Forxiga. It 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. It is currently being
assessed in patients with HF with preserved ejection fraction in
the DELIVER Phase III trial. Forxiga is also being tested in patients without T2D
following an acute myocardial infarction (MI) or heart attack in
the DAPA-MI Phase III trial - a first of its kind,
indication-seeking registry-based randomised controlled
trial.
AstraZeneca in CVRM
Cardiovascular, Renal and Metabolism (CVRM), part of
BioPharmaceuticals, forms one of AstraZeneca's three disease 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 for organ protection 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 CV 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 in
Oncology and BioPharmaceuticals, including 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. Centers for
Disease Control and Prevention. Chronic kidney disease in the
United States, 2021; 2021 [cited 2021 Jun 1]. Available from:
URL: https://www.cdc.gov/kidneydisease/publications-resources/2019-national-facts.html.
2. Segall L, et al. Heart failure
in patients with chronic kidney disease: a systematic integrative
review. Biomed Res
Int. 2014;2014:937398.
3. 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. Lancet. 2020;395(10225):709-733.
4. Jager KJ, et al. A single
number for advocacy and communication-worldwide more than 850
million individuals have kidney diseases. Nephrol Dial
Transplant. 2019;34(11):1803-1805.
5. National
Kidney Foundation. Kidney Disease: The Basics; 2021 [cited 2021 Jun
1]. Available from: URL: https://www.kidney.org/news/newsroom/factsheets/KidneyDiseaseBasics.
6. National
Kidney Foundation. Kidney Disease: Causes; 2015 [cited 2021 Jun 1].
Available from: URL: https://www.kidney.org/atoz/content/kidneydiscauses.
7. Briasoulis A, Bakris GL.
Chronic kidney disease as a coronary artery disease risk
equivalent. Curr Cardiol
Rep. 2013;15(3):340.
8. Heerspink HJL, et al.
Dapagliflozin in patients with chronic kidney
disease. N Engl J
Med. 2020;383(15):1436-1446.
9. Wiviott SD, et al., for the
DECLARE-TIMI 58 Investigators. Dapagliflozin and cardiovascular
outcomes in type-2 diabetes [article and supplementary
appendix]. N Engl J
Med. 2019:380:347-357.
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 June
2021
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By: /s/
Adrian Kemp
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Name:
Adrian Kemp
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|
Title:
Company Secretary
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