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
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.
Qtrilmet
recommended for approval in EU by CHMP
23 September 2019 07:00 BST
Qtrilmet recommended
for approval in EU by
CHMP for the treatment of type-2 diabetes
AstraZeneca today announced that Qtrilmet (metformin hydrochloride, saxagliptin and
dapagliflozin) modified-release tablets have been recommended for
marketing authorisation in the European Union for the treatment of
adults with type-2 diabetes (T2D).
The Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA) based its positive opinion 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 in reducing HbA1c
versus Forxiga combined with
metformin, Onglyza combined with metformin, or glimepiride
combined with metformin. The combination
of Forxiga, Onglyza and
metformin with or without sulphonylurea (SU) was non-inferior to
the combined use of insulin and metformin with or without SU in
reducing HbA1c.
The safety results of the individual medicines in these trials were
consistent with their known profile.
The CHMP recommended the marketing authorisation
for Qtrilmet to improve glycaemic control when metformin
with or without SU and either saxagliptin or dapagliflozin does not
provide adequate glycaemic control, or when T2D patients are
already being treated with metformin, saxagliptin and
dapagliflozin.
Qtrilmetis approved in the US
under the name Qternmet XR as an adjunct to diet and exercise to
improve glycaemic control in adults with T2D.
About Qtrilmet
Qtrilmetis 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 co-morbidities. 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 (CVRM) 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 us on Twitter@AstraZeneca.
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Relations
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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:
23 September
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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