AstraZeneca today announced that the Committee for Medicinal Products for Human
Use (CHMP) of the European Medicines Agency has issued a positive opinion,
recommending the approval of saxa/dapa (saxagliptin and dapagliflozin) tablets
for the treatment of adults with type-2 diabetes. The fixed-dose combination of
saxagliptin and dapagliflozin has the potential to be the first DPP-4i/SGLT-2i
combination product approved in Europe.

Saxa/dapa is a fixed-dose combination of saxagliptin and dapagliflozin being
developed as a treatment for patients with type-2 diabetes in adults aged
18 years and older. It is recommended to be indicated as a treatment to improve
glycaemic control when metformin and/or sulphonylurea and one of the mono
-components of saxa/dapa alone do not provide adequate glycaemic control, or
when a patient is already being treated with the free combination of saxagliptin
and dapagliflozin.

The submission included data from three studies in type-2 diabetes. In two
studies, the combination of dapagliflozin and saxagliptin with metformin
resulted in statistically significant reductions in HbA1c in comparison to
patients treated with placebo that required additional control to existing
saxagliptin and metformin or dapagliflozin and metformin therapy. An additional
study showed that the combination of dapagliflozin and saxagliptin added on to
metformin resulted in statistically superior reductions in HbA1c in comparison
to patients treated with dapagliflozin or saxagliptin alone added to metformin.
In these trials, the safety profile of saxa/dapa was similar to the known safety
profiles of saxagliptin and dapagliflozin.

The CHMP’s positive opinion will now be reviewed by the European Commission
(EC), which has the authority to approve medicines for the European Union (EU).
The final decision by the EC is expected in the coming months, and will be
applicable to all 28 EU member countries plus Iceland, Norway and Liechtenstein.

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 strategic 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 treatment 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, innovation-driven biopharmaceutical business that
focuses on the discovery, development and commercialisation of prescription
medicines, primarily for the treatment of diseases in three main therapy areas –
respiratory, inflammation, autoimmune disease (RIA), cardiovascular and
metabolic disease (CVMD) and oncology – as well as in infection and
neuroscience. 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


Neil Burrows UK/Global +44 7842 350541
Vanessa UK/Global +44 7880 400690
Karen UK/Global +44 7818 524012
Jacob Lund Sweden +46 8 553 260 20
Michele US +1 302 885 2677
Thomas Kudsk +44 7818 524185
Nick Stone RIA, CVMD +44 7717 618834
Henry Oncology Finance +44 7788 354619 +44 7881 615764
Craig Marks
Christer ING, Consensus Forecasts +44 7827 836825
Lindsey  CVMD, Oncology +1 240 543 7970
Mitch Chan  Oncology +1 240 477 3771
Dial / Toll +1 866 381 7277

Key: RIA – Respiratory, Inflammation and Autoimmunity, CVMD – Cardiovascular and
Metabolic Disease, ING – Infection, Neuroscience and Gastrointestinal

27 May 2016

– ENDS –