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 May
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
20-F X Form 40-F __
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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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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.
Qternmet
XR approved in the US for type-2 diabetes
3 May
2019 07:00 BST
Qternmet XR approved in the US for the treatment of
type-2 diabetes
The US
Food and Drug Administration (FDA) has
approved Qternmet
XR (dapagliflozin, saxagliptin and metformin
hydrochloride) extended release tablets as an oral adjunct
treatment to diet and exercise to improve glycaemic control in
adults with type-2 diabetes (T2D).
The
approval is based on two Phase III trials, which evaluated
combinations of dapagliflozin and saxagliptin on a background of
metformin over 24 weeks, in patients with inadequately-controlled
T2D.
In one
trial, treatment with 5mg dapagliflozin/5mg saxagliptin in addition
to metformin demonstrated statistically-significant decreases in
HbA1c (average blood glucose levels), and an increase in the number
of patients achieving the recommended HbA1c treatment goal of
<7%. In the second trial, treatment with 10mg dapagliflozin/5mg
saxagliptin in addition to metformin extended release demonstrated
statistically-significant decreases in HbA1c, and an increase in
the number of patients achieving an HbA1c <7%.
The
safety results of the individual medicines in these trials were
consistent with their known profile.
About Qternmet
XR
Qternmet XR is a
once-daily, oral medicine compromised of the selective
sodium-glucose cotransporter-2 (SGLT-2) inhibitor dapagliflozin,
the dipeptidyl peptidase-4 (DPP-4) inhibitor saxagliptin and
metformin hydrochloride extended release. Qternmet XR is approved in the US as an adjunct to diet
and exercise to improve glycaemic control in adults with type-2
diabetes.
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 astrazeneca.com and
follow us on Twitter @AstraZeneca.
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Media
Relations
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Gonzalo
Viña
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+44 203
749 5916
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Rob
Skelding
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Oncology
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+44 203
749 5821
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Rebecca
Einhorn
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Oncology
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+1 301
518 4122
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Matt
Kent
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BioPharma
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+44 203
749 5906
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Jennifer
Hursit
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Other
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+44
203 749 5762
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Christina Malmberg
Hägerstrand
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Sweden
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+46 8 552 53 106
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Michele
Meixell
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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
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Oncology
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+44 203
749 5797
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Christer
Gruvris
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BioPharma
(cardiovascular; metabolism)
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+44 203
749 5711
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Nick
Stone
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BioPharma
(respiratory; renal)
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+44 203
749 5716
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Josie
Afolabi
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Other
medicines
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+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 72 77
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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:
03 May
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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