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 November
2019
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
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by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(1):
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as permitted by Regulation S-T Rule 101(b)(7): ______
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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.
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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.
Qtrilmet approved in the
EU for the treatment of type-2 diabetes
15 November 2019 07:00 GMT
Qtrilmet approved
in the EU for the treatment of type-2 diabetes
AstraZeneca today announced that the European Commission (EC) has
approved Qtrilmet (metformin hydrochloride, saxagliptin and
dapagliflozin) modified-release tablets to improve glycaemic
control in adults with type-2 diabetes (T2D).
The approval is based on data from five Phase III trials which
evaluated combinations of Forxiga (dapagliflozin) and Onglyza (saxagliptin) on a background of metformin
in patients with inadequately controlled T2D. The primary endpoint
in these trials was mean change from baseline in HbA1c (average
blood glucose levels) at week 24 or 52.
Across the trials, the combination of Forxiga, Onglyza and metformin was superior at reducing HbA1c
compared to Forxiga with metformin, Onglyza with metformin, or glimepiride (an approved
T2D sulphonylurea (SU) medicine) with metformin. The combination
of Forxiga, Onglyza and metformin with or without glimepiride
showed non-inferiority in reducing HbA1c versus the combined use of
insulin and metformin with or without glimepiride. The safety
results of the individual medicines in these trials were consistent
with their known profile.
The EC has approved Qtrilmet to improve glycaemic control in adults with
T2D when metformin with or without SU and
either Onglyza or Forxiga does not provide adequate glycaemic control,
or when T2D patients are already being treated with
metformin, Onglyza and Forxiga.
Qtrilmet was approved
in the US in May 2019 under the name Qternmet XR as an adjunct to diet and exercise to
improve glycaemic control in adults with T2D.
About Qtrilmet
Qtrilmet is
a once-daily oral medicine comprised of the selective
sodium-glucose co-transporter 2 (SGLT2)
inhibitor Forxiga, the dipeptidyl peptidase-4 (DPP-4)
inhibitor Onglyza and metformin hydrochloride extended release
indicated as treatment in adults with T2D.
About AstraZeneca in CVRM
Cardiovascular, Renal & 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 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 and
Metabolism, and Respiratory. 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.
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Media
Relations
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Gonzalo
Viña
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Oncology
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749 5821
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518 4122
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Kent
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Hursit
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Meixell
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US
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Investor
Relations
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Thomas
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Wheeler
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749 5797
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Gruvris
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(CV, Metabolism)
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+44 203
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Nick
Stone
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BioPharmaceuticals
(Renal), ESG
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+44 203
749 5716
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Josie
Afolabi
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(Respiratory),
other
medicines
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749 5631
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Craig
Marks
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Finance,
fixed income
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7881 615 764
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Jennifer
Kretzmann
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Corporate
access, retail investors
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US
toll-free
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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:
15 November
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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