Blueprint
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 2018
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 gets
positive result in DECLARE-TIMI 58
This announcement contains inside information
24 September 2018 07:00 BST
Farxiga achieved a positive result in the Phase III
DECLARE-TIMI 58 trial, a large cardiovascular outcomes trial in
17,000 patients with type-2 diabetes
Farxiga met the primary composite endpoint of a
statistically-significant reduction
in hospitalisation for heart failure or CV death in a broad
patient population
Results confirmed the well-established safety profile of
Farxiga
AstraZeneca today announced positive results from the Phase III
DECLARE-TIMI 58 cardiovascular (CV) outcomes trial (CVOT)
for Farxiga (dapagliflozin), the broadest SGLT2
inhibitor CVOT conducted to date. The trial evaluated the CV
outcomes of Farxiga vs. placebo over a period of up to five
years, across 33 countries and in more than 17,000 adults with
type-2 diabetes (T2D) who have multiple CV risk factors or
established CV disease.
In the DECLARE (Dapagliflozin Effect on Cardiovascular Events)-TIMI
58 trial, Farxiga met its primary safety endpoint of
non-inferiority for major adverse cardiovascular events
(MACE). Farxiga achieved a statistically-significant
reduction in the composite endpoint of hospitalisation for heart
failure (hHF) or CV death, one of the two primary efficacy
endpoints. Additionally, fewer MACE events were observed
with Farxiga for the other primary efficacy endpoint,
however, this did not reach statistical
significance.
Data from DECLARE-TIMI 58 confirmed the well-established safety
profile of Farxiga.
Elisabeth Björk, Vice President, Head of Cardiovascular, Renal
and Metabolism, Global Medicines Development said:
"Farxiga has achieved a statistically-significant and
clinically-important reduction in hospitalisation for heart failure
or CV death in a broad range of patients with type-2 diabetes and
cardiovascular risk. The results from this landmark trial
are especially important since heart failure is an early and
frequent complication of diabetes and associated with
hospitalisations that result in a considerable societal and
economic burden." 1-7
Dr Stephen Wiviott of Brigham and Women's Hospital and
Harvard Medical School, a senior investigator with the
Thrombolysis in Myocardial Infarction (TIMI) study group and
co-principal investigator of the trial, commented: "The
DECLARE-TIMI 58 results offer compelling evidence that
dapagliflozin helps to address an important medical need among a
diverse group of patients with type-2 diabetes by reducing the
composite of hospitalisation for heart failure or CV death, with a
safety profile supportive of broad use."
Detailed trial results will be presented on 10 November at the
American Heart Association Scientific Sessions 2018 in Chicago,
USA.
About DECLARE-TIMI 58
DECLARE (Dapagliflozin Effect on Cardiovascular Events)-TIMI
58 is an AstraZeneca-sponsored, randomised, double-blinded,
placebo-controlled, multicentre trial designed to evaluate the
effect of Farxigacompared with placebo on CV outcomes in adults
with T2D at risk of CV events, including patients with multiple CV
risk factors or established CV disease. DECLARE included more than
17,000 patients across 882 sites in 33 countries and was
independently run in collaboration with academic investigators from
the TIMI study group (Boston, USA) and the Hadassah Hebrew
University Medical Center (Jerusalem, Israel).8
DECLARE is part of the extensive DapaCare clinical programme
for Farxiga, which will enrol patients in randomised clinical
trials, including a wide range of mechanistic studies, and is
supported by a multinational real-world evidence study (CVD-REAL).
The DapaCare clinical programme will generate data across a
spectrum of people with CV risk factors, established CV disease and
varying stages of renal disease, both with and without T2D. DECLARE
is paving the way for three Phase III trials: Dapa-HF, DELIVER and
Dapa-CKD.
About Farxiga (dapagliflozin)
Farxiga is a
first-in-class, oral, once-daily selective inhibitor of human
sodium-glucose co-transporter 2 (SGLT2) indicated as both
monotherapy and as part of combination therapy to improve glycaemic
control, with the additional benefits of weight loss and blood
pressure reduction, as an adjunct to diet and exercise in adults
with T2D. Farxiga is not indicated to reduce the risk of CV
events, CV death or hHF. Farxiga has a robust clinical trial programme of
more than 35 completed and ongoing Phase IIb/III trials in over
35,000 patients, as well as more than 1.8 million patient-years'
experience.
About AstraZeneca in Cardiovascular, Renal & Metabolism
(CVRM)
Cardiovascular, renal and metabolism together form one of
AstraZeneca's main therapy areas and 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. Our 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.
About AstraZeneca
AstraZeneca 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. AstraZeneca operates in over 100
countries and its innovative medicines are used by millions of
patients worldwide.
For more information, please visit www.astrazeneca.com and
follow us on Twitter @AstraZeneca.
|
Media Relations
|
|
|
|
Karen
Birmingham
|
UK/Global
|
+44 203 749 5634
|
|
Rob
Skelding
|
UK/Global
|
+44 203 749 5821
|
|
Matt
Kent
|
UK/Global
|
+44 203 749 5906
|
|
Gonzalo
Viña
|
UK/Global
|
+44 203 749 5916
|
|
Jacob
Lund
|
Sweden
|
+46 8 553 260 20
|
|
Michele
Meixell
|
US
|
+1 302 885 2677
|
|
Investor Relations
|
|
|
|
Thomas
Kudsk Larsen
|
|
+44 203 749 5712
|
|
Henry
Wheeler
|
Oncology
|
+44 203 749 5797
|
|
Christer
Gruvris
|
Cardiovascular; Metabolism
|
+44 203 749 5711
|
|
Nick
Stone
|
Respiratory; Renal
|
+44 203 749 5716
|
|
Josie
Afolabi
|
Other
|
+44 203 749 5631
|
|
Craig
Marks
|
Finance; Fixed Income
|
+44 7881 615 764
|
|
Jennifer
Kretzmann
|
Retail Investors
|
+44 203 749 5824
|
|
US
toll-free
|
|
+1 866 381 7277
|
Adrian Kemp
Company Secretary
AstraZeneca PLC
References
1.
International Diabetes Federation, IDF Diabetes Atlas, Eighth
Edition Update, 2017.
2. Shah
AD, Langenberg C, Rapsomaniki E, et al. Type 2 diabetes and
incidence of cardiovascular diseases: a cohort study in 1·9
million people. Lancet Diabetes Endocrinol.
2015;3:105-113.
3. Faden, et al. The increasing
detection of asymptomatic left ventricular dysfunction in patients
with type 2 diabetes mellitus without overt cardiac disease: Data
from the SHORTWAVE study. Diabetes Res Clin
Pract.
2013;101(3):309-16.
4.
Low Wang, Cecilia C. et al. "Atherosclerotic Cardiovascular Disease
and Heart Failure in Type 2 Diabetes - Mechanisms, Management, and
Clinical Considerations." Circulation 133.24 (2016): 2459-2502.
PMC. Web. 19 Sept. 2018.
5. Heidenreich,
Paul A. et al. "Forecasting the Impact of Heart Failure in the
United States: A Policy Statement From the American Heart
Association." Circulation. Heart failure 6.3 (2013): 606-619. PMC.
Web. 19 Sept. 2018.
6. Nichols
GA, Brown JB: The impact of cardiovascular disease on medical care
costs in subjects with and without type 2 diabetes. Diabetes Care
25:482-486, 2002.
7. Nichols, et al.
The incidence of congestive heart failure in type 2 diabetes.
Diabetes Care, Volume 27, Number 8, Aug.
2004: http://care.diabetesjournals.org/content/27/8/1879.
8. Multicenter Trial
to Evaluate the Effect of Dapagliflozin on the Incidence of
Cardiovascular Events (DECLARE-TIMI 58). Sept.
2018. https://clinicaltrials.gov/ct2/show/NCT01730534.
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:
24 September 2018
|
|
By: /s/
Adrian Kemp
|
|
|
Name:
Adrian Kemp
|
|
|
Title:
Company Secretary
|