a9764h
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 August 2021
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
Indicate
by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
Form
20-F X Form 40-F __
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(1):
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(7): ______
Indicate
by check mark whether the registrant by furnishing the information
contained in this Form is also thereby furnishing the information
to the Commission pursuant to Rule 12g3-2(b) under the Securities
Exchange Act of 1934.
Yes __
No X
If
“Yes” is marked, indicate below the file number
assigned to the Registrant in connection with Rule 12g3-2(b):
82-_____________
AstraZeneca PLC
INDEX
TO EXHIBITS
1.
Forxiga
approved in the EU for CKD
09 August 2021 07:05 BST
Forxiga approved in the EU for the treatment of
chronic
kidney disease in patients with and without type-2
diabetes
Approval based on unprecedented DAPA-CKD Phase III data is the
most
significant advancement in chronic kidney disease in more than 20
years
AstraZeneca's Forxiga (dapagliflozin), a sodium-glucose
cotransporter 2 (SGLT2) inhibitor, has been approved in the
European Union (EU) for the treatment of chronic kidney disease
(CKD) in adults with and without type-2 diabetes
(T2D).
The approval by the European Commission is based on positive
results from the DAPA-CKD Phase III trial. The decision
follows the recommendation for
approval by the Committee
for Medicinal Products for Human Use of the European Medicines
Agency.
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 840 million people worldwide and approximately 47 million
in the EU. 3,4 However,
diagnosis rates remain low and up to 90% of patients are unaware
they have the disease.3
The co-chair of the DAPA-CKD Phase III trial and its executive
committee, Prof. Hiddo L. Heerspink, University Medical Center
Groningen, the Netherlands, said: "Today's approval establishes
dapagliflozin as the first SGLT2 inhibitor approved for the
treatment of chronic kidney disease regardless of diabetes status
in the EU. Based on the unprecedented results from the DAPA-CKD
Phase III trial, dapagliflozin delays disease progression providing
physicians a critical opportunity to improve the prognosis of
patients with chronic kidney disease."
Mene Pangalos, Executive Vice President, BioPharmaceuticals
R&D, said: "Today's approval is an important milestone
for Forxiga and has the potential to transform treatment
for the millions of people living with chronic kidney disease in
the EU. While new medicines like Forxiga advance the standard of care, we are also
committed to the prevention and early detection of
this often debilitating and
life-threatening disease."
The DAPA-CKD Phase III trial demonstrated
that Forxiga, on top of standard-of-care (SoC) treatment with
an angiotensin-converting enzyme inhibitor or an angiotensin
receptor blocker, reduced the relative risk of worsening of renal
function, onset of end-stage kidney disease (ESKD), or risk of
cardiovascular (CV) or renal death by 39% (the primary composite
endpoint), compared to placebo (absolute risk reduction [ARR]=5.3%,
p<0.0001) in patients with CKD Stages 2-4 and elevated urinary
albumin excretion.5
Forxiga also significantly
reduced the relative risk of death from any cause by 31% (ARR=2.1%,
p=0.0035) compared to placebo.5 The
safety and tolerability of Forxiga were consistent with the well-established
safety profile of the medicine.
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
is currently under review in Japan and several
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 regardless of diabetes
status.
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
SoC. 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 SGLT2 inhibitor. Research has
shown Forxiga's efficacy in preventing and delaying
cardiorenal disease, while also protecting the organs - important
findings given the underlying links between the heart, kidneys and
pancreas.8-10 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.11-13
Forxiga is approved as an
adjunct to diet and exercise to improve glycaemic control in adults
with T2D and in T2D to reduce the risk of hHF or CV death when
added to SoC based on the findings of the DECLARE-TIMI
58 Phase III CV outcomes
trial.9 Forxiga is
also approved for the treatment of
HFrEF and the treatment of
CKD based on the findings
of the DAPA-HF and DAPA-CKD Phase
III trials.8,10
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. Forxiga is currently 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 main 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, Rare Diseases, 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 (CDC) [Internet]. Chronic kidney
disease in the United States, 2019; [cited 2021 Jul 08]. Available
from:
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.
Heerspink
H. DAPA-CKD - Dapagliflozin in Patients with Chronic Kidney
Disease. Presented at: ESC Congress 2020 - The Digital Experience,
2020 August 29 - September 01.
6.
National Kidney Foundation
[Internet]. Kidney Disease: Causes, 2015; [cited 2021 Jul 08].
Available from: 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.
10.
McMurray J, et al. Dapagliflozin in patients with
heart failure and reduced ejection
fraction. N Engl J
Med. 2019;
381:1995-2008
11.
Mayo Clinic [Internet]. Heart
failure, 2020; [cited 2021 Jul 09]. Available
from: https://www.mayoclinic.org/diseases-conditions/heart-failure/symptoms-causes/syc-20373142.
12.
Centers for Disease Control and
Prevention (CDC) [Internet]. A snapshot: Diabetes in the
United States, 2020; [cited 2021 Jul 09]. Available
from: https://www.cdc.gov/diabetes/library/socialmedia/infographics/diabetes.html.
13.
National Institute of Diabetes
and Digestive And Kidney Diseases (NIH) [Internet]. Heart disease
& kidney disease, 2016; [cited 2021 Jul 09]. Available
from: https://www.niddk.nih.gov/health-information/kidney-disease/heart-disease.
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:
9 August 2021
|
By: /s/
Adrian Kemp
|
|
Name:
Adrian Kemp
|
|
Title:
Company Secretary
|