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
2019
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 label
updated in the EU in type-2 diabetes
5 August 2019 07:00 BST
Forxiga label updated in the EU in type-2
diabetes
Label updated with positive cardiovascular outcomes and renal data
from the DECLARE-TIMI 58 trial
AstraZeneca today announced that the European Commission has
approved an update to the marketing authorisation
for Forxiga (dapagliflozin) to include positive
cardiovascular (CV) outcomes and renal data from the Phase III
DECLARE-TIMI 58 trial in adults with type-2 diabetes (T2D). The
trial enrolled a majority of patients with no existing
cardiovascular disease.
Mene Pangalos, Executive Vice President, BioPharmaceuticals
R&D, said: "For patients with type-2 diabetes, heart
failure is one of the earliest cardiovascular complications before
heart attack or stroke. In the Phase III DECLARE-TIMI 58
trial, Forxiga reduced
the composite endpoint of hospitalisation for heart failure or
cardiovascular death in patients with type-2 diabetes, and we look
forward to bringing these additional benefits of the
medicine to people with type-2 diabetes in the
EU."
In the Phase III DECLARE-TIMI 58 trial, Forxiga achieved a statistically-significant
reduction in the composite endpoint of hospitalisation for heart
failure or CV death versus placebo, one of the two primary efficacy
endpoints. There were fewer major adverse CV events observed
with Forxiga for the other primary efficacy endpoint,
however this did not reach statistical
significance.
The Phase III DECLARE-TIMI 58 trial confirmed the well-established
safety profile of Forxiga. The trial showed no significant imbalance
with Forxiga versus placebo in amputations, fractures,
bladder cancer or Fournier's gangrene.
Inclusion of the DECLARE-TIMI 58 trial data to the medicine's label
is currently under regulatory review in the US and
China.
About DECLARE-TIMI 58
DECLARE (Dapagliflozin Effect on Cardiovascular Events)-TIMI 58 is
the largest CV outcomes trial conducted for a selective
inhibitor of human sodium-glucose co-transporter 2 (SGLT2) to date
in a broad patient population. It is an AstraZeneca-sponsored,
Phase III, randomised, double-blinded, placebo-controlled,
multicentre trial, designed to evaluate the effect
of Forxiga compared 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 and also
assessed key renal secondary endpoints. The trial 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, US) and the Hadassah Hebrew
University Medical Center (Jerusalem, Israel).
The full results of the DECLARE-TIMI
58 trial
were published in The
New England Journal of Medicine in January 2019.
About Forxiga
Forxiga (dapagliflozin) is
a first-in-class, oral once-daily SGLT2 inhibitor 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. Forxiga 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.
About AstraZeneca in CV, Renal & Metabolism (CVRM)
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 comorbidities. 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.
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 astrazeneca.com and
follow us on Twitter @AstraZeneca.
Media
Relations
|
|
|
Gonzalo
Viña
|
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+44 203
749 5916
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Rob
Skelding
|
Oncology
|
+44 203
749 5821
|
Rebecca
Einhorn
|
Oncology
|
+1 301
518 4122
|
Matt
Kent
|
BioPharmaceuticals
|
+44 203
749 5906
|
Jennifer
Hursit
|
Other
|
+44
203 749 5762
|
Christina Malmberg
Hägerstrand
|
Sweden
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+46 8 552 53 106
|
Michele
Meixell
|
US
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+1 302
885 2677
|
|
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Investor
Relations
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Thomas
Kudsk Larsen
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+44 203
749 5712
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Henry
Wheeler
|
Oncology
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+44 203
749 5797
|
Christer
Gruvris
|
BioPharmaceuticals (CV,
metabolism)
|
+44 203
749 5711
|
Nick
Stone
|
BioPharmaceuticals
(respiratory, renal)
|
+44 203
749 5716
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Josie
Afolabi
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Other
medicines
|
+44 203
749 5631
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Craig
Marks
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Finance,
fixed income
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+44
7881 615 764
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Jennifer
Kretzmann
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Corporate
access, retail investors
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+44 203
749 5824
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US
toll-free
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+1 866
381 7277
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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:
5th
August
2019
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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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