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2019-11-15

AstraZeneca: Qtrilmet approved in the EU f or 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 (http://www.astrazeneca.com/) and follow
the Company on Twitter @AstraZeneca
(https://twitter.com/AstraZeneca).

Media Relations
Gonzalo Viña +44 203 749 5916
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 Sweden +46 8 552 53 106
Malmberg
Hägerstrand
Michele Meixell US +1 302 885 2677

Investor
Relations
Thomas Kudsk +44 203 749 5712
Larsen
Henry Wheeler Oncology +44 203 749 5797
Christer BioPharmaceuticals (CV, +44 203 749 5711
Gruvris Metabolism)
Nick Stone BioPharmaceuticals +44 203 749 5716
(Renal), ESG
Josie Afolabi BioPharmaceuticals +44 203 749 5631
(Respiratory), other
medicines
Craig Marks Finance, fixed income +44 7881 615 764
Jennifer Corporate access, retail +44 203 749 5824
Kretzmann investors
US toll-free +1 866 381 72 77

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