AstraZeneca Receives Complete Response Letter from US FDA for SaxaGLIPTIN / dapaGLIFLOZIN Fixed-Dose-Combination

AstraZeneca (http://www.astrazeneca.com/) today announced that the US Food and
Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding
the New Drug Application (NDA) for the investigational fixed-dose combination of
saxagliptin and dapagliflozin for the treatment of adult patients with type 2
diabetes.

The CRL states that more clinical data are required to support the application.
This includes clinical trial data from ongoing or completed studies and may
require information from new studies. AstraZeneca will work closely with the FDA
to determine the appropriate next steps for the NDA and remains committed to the
development of the saxagliptin/ dapagliflozin fixed-dose combination.

This announcement does not affect ongoing interactions with other health
authorities as part of these individual application procedures.  Based on the
information available, the CRL is not expected to affect individual components
of saxagliptin or dapagliflozin, which are approved for the treatment of adult
patients with type 2 diabetes.

About Type 2 Diabetes
Diabetes is estimated to affect 29.1 million people in the US and more than 387
million people worldwide. The prevalence of diabetes is projected to reach more
than 592 million people worldwide by 2035 and type 2 diabetes accounts for
approximately 90-95 percent of all diagnosed cases in the US. Type 2 diabetes is
a chronic and progressive disease characterised by multiple pathophysiologic
defects leading to elevated glucose levels. Significant unmet needs still exist,
as many patients remain inadequately controlled on their current glucose
-lowering regimen. It is estimated that nearly half of people living with type 2
diabetes are not achieving recommended HbA1c goals based on guidelines
established by professional societies and advocacy organizations for diabetes
management.

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, heart failure, 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 DPP-4 Inhibition
Incretin hormones are released into the bloodstream in response to meals and
increase insulin release in a glucose-dependent manner but are inactivated by
the DPP-4 enzyme within minutes. DPP-4 inhibitors slow the inactivation of the
incretin hormones, thereby reducing fasting and postprandial glucose
concentrations in a glucose-dependent manner.

About SGLT-2 Inhibition
The kidney plays a contributing role in maintaining normal glucose balance, in
part by filtering and subsequently reabsorbing glucose back into circulation.
SGLT-2, a sodium-glucose cotransporter found predominantly in the kidney, is
responsible for the majority of glucose reabsorption. Selective inhibition of
SGLT-2 reduces the reabsorption of glucose and lowers the renal threshold for
glucose thereby enabling its removal via the urine.



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 cardiovascular, metabolic,
respiratory, inflammation, autoimmune, oncology, infection and neuroscience
diseases. 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.

CONTACTS

Media Enquiries
Esra Erkal-Paler                              UK/Global         +44 20 7604 8030
Vanessa Rhodes                                UK/Global         +44 20 7604 8037
Ayesha Bharmal                                UK/Global         +44 20 7604 8034
Karen Birmingham                              UK/Global         +44 20 7604 8120
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Michele Meixell                               US                +1 302 885 2677
Investor Enquiries    irteam@astrazeneca.com
UK
Thomas Kudsk Larsen   Oncology                +44 20 7604 8199  +44 7818 524185
Eugenia Litz          RIA                     +44 20 7604 8233  +44 7884 735627
Nick Stone            CVMD                    +44 20 7604 8236  +44 7717 618834
Craig Marks           Finance                 +44 20 7604 8591  +44 7881 615764
Christer Gruvris                              +44 20 7604 8126  +44 7827 836825
US
Lindsey Trickett      Oncology, ING           +1 301 398 5118   +1 240 543 7970
Mitch Chan            Oncology                +1 301 398 1849   +1 240 477 3771
Dial / Toll-Free                              +1 301 398 3251    +1 866 381 7277

Key: RIA - Respiratory, Inflammation and Autoimmunity, CVMD - Cardiovascular and
Metabolic Disease,

ING - Infection, Neuroscience and Gastrointestinal

16 October 2015