a7320k
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 January 2021
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
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United
Kingdom
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
Farxiga granted Priority Review in the US for the treatment of
patients with chronic kidney disease
6 January 2021 07:00 GMT
Farxiga granted Priority Review in the
US
for the treatment of patients with chronic kidney
disease
Farxiga could become the first SGLT2 inhibitor approved to
treat
patients with chronic kidney disease, with and without type-2
diabetes
AstraZeneca's Farxiga (dapagliflozin) has been granted Priority
Review in the US for the treatment of new or worsening chronic
kidney disease (CKD) in adults with and without type-2 diabetes
(T2D).
The Food and Drug Administration (FDA) grants Priority Review to
regulatory submissions for medicines that offer significant
advances over available options by demonstrating safety or efficacy
improvements, preventing serious conditions, or enhancing patient
compliance. The Prescription Drug User Fee Action date, the day the
FDA targets for their regulatory decision, will be during the
second quarter of 2021.
CKD, a condition defined by decreased kidney function, is often
associated with a heightened risk of heart disease or stroke, or
the need for dialysis or kidney transplant.1-3 CKD is
expected to become the world's fifth leading cause of mortality by
2040.4 Currently
in the US, 37 million people
are estimated to have CKD.1
Mene Pangalos, Executive Vice President, BioPharmaceuticals
R&D, said: "This decision brings us a step closer to
delivering this new treatment option for the millions of patients
living with chronic kidney disease in the
US. Farxiga has
the potential to be a truly transformational medicine across a
breadth of diseases, including type-2 diabetes, heart failure with
reduced ejection fraction and, if approved, chronic kidney
disease."
The acceptance of the regulatory submission by the FDA and the
granting of Priority Review was based on clinical evidence from the
DAPA-CKD Phase III trial. The trial showed
that Farxiga, on top of standard of care consisting of an
angiotensin-converting enzyme inhibitor (ACEi) or an angiotensin
receptor blocker (ARB), reduced the risk of the composite of
worsening of renal function or risk of cardiovascular (CV) or renal
death by 39%, the primary 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. It
also significantly reduced the risk of death from any cause by 31%
(ARR 2.1%, p=0.0035) compared to placebo.5 The
safety and tolerability of Farxiga were consistent with the well-established
safety profile of the medicine.
In March
2020, an independent Data
Monitoring Committee recommended the trial be stopped early, based
on its determination of overwhelming efficacy. Detailed
results from the DAPA-CKD trial
were shared in August
2020 and published in The
New England Journal of Medicine.6
In October
2020, Farxiga received Breakthrough Therapy Designation in
the US for patients with CKD with and without T2D. In the
US, Farxiga is indicated as an adjunct to diet and
exercise to improve glycaemic control in adults with T2D.
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.
Chronic kidney disease
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)7 affecting
nearly 850 million people worldwide, many of them still
undiagnosed.8 The
most common causes of CKD are diabetes, hypertension and
glomerulonephritis.9 CKD
is associated with significant patient morbidity and an increased
risk of CV events, such as heart failure (HF) and
premature death. In its most severe form, known as end-stage kidney
disease (ESKD), kidney damage and deterioration of kidney function
have progressed to the stage where dialysis or kidney
transplantation are required.1 The
majority of patients with CKD will die from CV causes before
reaching ESKD.10
DAPA-CKD
DAPA-CKD was an international, multi-centre, randomised,
double-blinded trial in 4,304 patients designed to evaluate the
efficacy of dapagliflozin 10mg,
compared with placebo, in patients with CKD Stages 2-4 and elevated
urinary albumin excretion, with and without
T2D. Farxiga was
given once daily in addition to standard of care consisting of an
ACEi or an ARB. 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 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.6
Farxiga
Farxiga (dapagliflozin) is
a first-in-class, oral, once-daily sodium-glucose co-transporter-2
(SGLT2) inhibitor.
The research for Farxiga 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 Farxiga 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. Farxiga 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 Farxiga achieved unprecedented reduction in the
composite risk of kidney failure and CV or renal death in patients
with CKD versus placebo, and is now the first SGLT2 inhibitor shown
to significantly prolong survival in a renal outcomes trial for
this patient population and provide organ
protection. Farxiga is not indicated for the treatment of
CKD.
DapaCare is a robust programme of clinical trials to evaluate the
potential CV, renal and organ protection benefits
of Farxiga. 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. Farxiga 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) 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 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 cardiovascular 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, 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. Centers for
Disease Control and Prevention (CDC). Chronic Kidney Disease in the
United States, 2019; 11 March 2019 [cited 22 October 2020].
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):709-33.
4. Foreman KJ et
al. Forecasting Life Expectancy, Years of Life Lost, and
All-Cause and Cause-Specific Mortality for 250 Causes of Death:
Reference and Alternative Scenarios for 2016-40 for 195 Countries
and Territories. Lancet 2018; 392:2052-90.
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. Heerspink HJL et al.
Dapagliflozin in Patients with Chronic Kidney
Disease. N Engl J
Med 2020;
383(15):1436-46.
7. Kidney Disease: Improving
Global Outcomes (KDIGO) Anemia Work Group. KDIGO Clinical Practice
Guideline for Anemia in Chronic Kidney
Disease. Kidney International
Supplement 2012;
2:279-335.
8. 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):1803-5.
9. National Kidney
Foundation. Kidney Disease: Causes; 2015 [cited 2020 Sep 23].
Available from: URL: https://www.kidney.org/atoz/content/kidneydiscauses
10. Briasoulis A, Bakris GL. Chronic
Kidney Disease as a Coronary Artery Disease Risk
Equivalent. Current Cardiology
Reports 2013;
15(3):340.
Adrian Kemp
Company Secretary
AstraZeneca PLC
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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:
06 January
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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