QTERN (saxa/dapa) EU approved for type-2 diabetes

This announcement contains inside information



19 July 2016 14:15



ASTRAZENECA RECEIVES APPROVAL IN THE EU FOR QTERN (SAXAGLIPTIN AND
DAPAGLIFLOZIN) FOR TREATMENT OF TYPE 2 DIABETES

AstraZeneca today announced that the European Commission (EC) has approved Qtern
(saxagliptin/dapagliflozin) tablets for the treatment of type 2 diabetes in all
28 EU member countries plus Iceland, Liechtenstein and Norway. The fixed-dose
combination of saxagliptin and dapagliflozin is the first DPP-4i/SGLT-2i
combination product to be approved in Europe.

Qtern is indicated for adults with type 2 diabetes aged 18 years and older to
improve glycaemic control when metformin and/or sulphonylurea and one of the
mono-components of Qtern alone do not provide adequate control, or when a
patient is already being treated with the free combination of saxagliptin and
dapagliflozin.

Elisabeth Björk, Vice President, Head of Cardiovascular and Metabolic Diseases,
Global Medicines Development at AstraZeneca said: "Nearly half of all people
with type 2 diabetes are unable to reach their treatment goal and so risk
developing complications due to hyperglycaemia. Qtern is the first combination
product of its kind approved in Europe and an important new treatment option to
help patients reach their goals through powerful HbA1c reduction."

The approval is based on data from three trials in type 2 diabetes submitted to
the European Medicines Agency. In two trials, the combination of saxagliptin and
dapagliflozin with metformin resulted in statistically significant reductions in
HbA1c in comparison to patients treated with placebo. An additional trial showed
that the combination of saxagliptin and dapagliflozin added to metformin
resulted in statistically superior reductions in HbA1c in comparison to patients
treated with saxagliptin or dapagliflozin alone added to metformin. In these
trials, the safety profile of Qtern was similar to the known safety profiles of
saxagliptin and dapagliflozin.

About AstraZeneca in Diabetes

AstraZeneca is pushing the boundaries of science with the goal of developing
life-changing medicines that aim to reduce the global burden and complications
of diabetes. Our current portfolio consists of the three newest classes of non
-insulin, anti-diabetic treatments that support individualised treatment
approaches: SGLT-2 inhibitors, GLP-1 receptor agonists and DPP-4 inhibitors.

As a main therapy area for the company, we are focusing our research and
development efforts on diverse populations and patients with significant co
-morbidities, such as cardiovascular disease, obesity, non-alcoholic
steatohepatitis (NASH) and chronic kidney disease.

Our commitment to diabetes is exemplified by the depth and breadth of our global
clinical research programme. This commitment is advancing understanding of the
treatment effects of our diabetes medicines in broad patient populations, as
well as exploring combination product approaches to help more patients achieve
treatment success earlier in their disease progression. Our ambition is to
reduce the long-term impact of diabetes.

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 - Respiratory and
Autoimmunity, Cardiovascular and Metabolic Diseases, and Oncology. The Company
is also active in inflammation, infection and neuroscience through numerous
collaborations. AstraZeneca operates in over 100 countries and its innovative
medicines are used by millions of patients worldwide. For more information
please visit: www.astrazeneca.com

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