a9316a
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 October 2020
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.
Farxiga
granted US BTD in chronic kidney disease
2
October 2020 07:00 BST
Farxiga granted
Breakthrough Therapy Designation
in US for chronic kidney
disease
Designation follows DAPA-CKD Phase III trial results in which
Farxiga demonstrated unprecedented reduction in the risk of kidney
failure and cardiovascular or renal death in patients with chronic
kidney disease
AstraZeneca's Farxiga (dapagliflozin) has been granted
Breakthrough Therapy Designation (BTD) in the US for patients with
chronic kidney disease (CKD), with and without type-2 diabetes
(T2D).
CKD is a serious, progressive condition defined by decreased kidney
function and is often associated with an increased risk of heart
disease or stroke.1,2,3 In
the US, 37 million people are estimated to have
CKD.1
The Food and Drug Administration (FDA)'s BTD is designed to
accelerate the development and regulatory review of potential new
medicines that are intended to treat a serious condition and
address a significant unmet medical need. The new medicine needs to
have shown encouraging early clinical results that demonstrate
substantial improvement on a clinically significant endpoint over
available medicines.4
Mene Pangalos, Executive Vice President, BioPharmaceuticals
R&D, said: "There is a serious, unmet need for better and
earlier treatment options for patients with chronic kidney disease.
Following the ground-breaking DAPA-CKD results, the Breakthrough
Therapy Designation is further testament
to Farxiga's
potential to slow the progression of chronic kidney disease. We
look forward to working with the FDA to
make Farxiga available to patients as quickly as
possible."
The FDA granted BTD based on clinical evidence from the DAPA-CKD
trial. The detailed
results presented in
August demonstrated that Farxiga 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
(absolute risk reduction [ARR] = 5.3%, p<0.0001) in patients
with CKD while also significantly reducing death from any
cause by 31% (ARR = 2.1%, p=0.0035) compared to
placebo.5
In the US, Farxiga is indicated as an adjunct to diet and
exercise to improve glycaemic control in adults with T2D and to
reduce the risk of hospitalisation for heart failure (hHF) in
patients with T2D and established CV disease or multiple CV risk
factors. In May, Farxiga was approved in the
US to reduce the risk of
CV death and hHF in adults with heart failure (HF) (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) affecting nearly 700 million people worldwide, many of
them still undiagnosed.3,6-8 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,3 such
as HF and premature death.2 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 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 detailed results
were announced in August
2020.
Farxiga
Farxiga (dapagliflozin) is
a first-in-class, oral, once-daily sodium-glucose co-transporter-2
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 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/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. 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.
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. The Lancet 2020; 395(10225):709-33.
4. U.S. Food and Drug
Administration. Frequently Asked Questions: Breakthrough Therapies
[cited 2020 Sep 28]. Available from: URL: https://www.fda.gov/regulatory-information/food-and-drug-administration-safety-and-innovation-act-fdasia/frequently-asked-questions-breakthrough-therapies
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.
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.
7. 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.
8. National Kidney
Foundation. Kidney Disease: The Basics; 2020 [cited 2020 Sep 23].
Available from: URL: https://www.kidney.org/news/newsroom/factsheets/KidneyDiseaseBasics
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
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:
02
October
2020
|
By: /s/
Adrian Kemp
|
|
Name:
Adrian Kemp
|
|
Title:
Company Secretary
|