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 July
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
receives positive EU CHMP opinion for
1 July 2019 07:00 BST
Forxiga receives positive EU CHMP opinion
for
DECLARE-TIMI 58 cardiovascular outcomes data
AstraZeneca today announced that the European Medicines Agency's
Committee for Medicinal Products for Human Use (CHMP) has
recommended a change to the European marketing authorisation
for Forxiga (dapagliflozin) in patients with type-2
diabetes (T2D) to include cardiovascular (CV) outcomes data
from the Phase III DECLARE-TIMI 58 trial.
Mene Pangalos, Executive Vice President, BioPharmaceuticals
R&D, said: "We are pleased with this positive opinion for the
cardiovascular outcomes and renal data
for Forxiga and
this recommendation acknowledges that even more people with type-2
diabetes could benefit from this medicine."
In DECLARE-TIMI 58, the largest and broadest CV outcomes trial
conducted for a SGLT2 inhibitor to date, 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.
DECLARE-TIMI 58 confirmed the well-established safety profile
of Forxiga. The trial showed no imbalance
with Forxiga versus placebo in amputations, fractures,
bladder cancer or Fournier's gangrene.
Regulatory reviews and submissions are ongoing in several
countries, including the US, China and Japan.
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 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. 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 DECLARE-TIMI
58 were published
in The
New England Journal of Medicine in January 2019.
About Forxiga
Forxiga (dapagliflozin) 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. 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 1.8
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
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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:
01 July
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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