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2018-05-21

AstraZeneca: Regulatory submission in Japan for Forxiga in type-1 diabetes

Japan submission follows European regulatory submission acceptance in
March 2018

AstraZeneca has submitted a supplemental new drug application (sNDA)
to Japan's Pharmaceuticals and Medical Devices Agency (PMDA) for the
use of Forxiga (dapagliflozin), a selective sodium-glucose
co-transporter 2 (SGLT2) inhibitor, as an oral adjunct treatment to
insulin in adults with type-1 diabetes (T1D).

The Japan sNDA is based on Phase III data from the DEPICT
(Dapagliflozin Evaluation in Patients with Inadequately Controlled
Type 1 Diabetes) clinical programme for Forxiga in T1D and a
dedicated trial in Japanese patients (trial D1695C00001). Results
showed that Forxiga, when given as an oral adjunct to adjustable
insulin in patients with inadequately-controlled T1D, demonstrated
significant and clinically-meaningful reductions from baseline in
HbA1c, weight and total daily insulin dose at 24 and 52 weeks,
compared to placebo, at both 5mg and 10mg doses.

Forxiga is also under regulatory review in Europe for use as an oral
adjunct treatment to insulin in adults with T1D.

About the DEPICT Clinical Programme

The DEPICT clinical programme consists of two clinical trials:
DEPICT-1 (NCT02268214) and DEPICT-2 (NCT02460978). DEPICT-1 and
DEPICT-2 are 24-week, randomised, double-blind, parallel-controlled
trials designed to assess the effects of Forxiga 5mg or 10mg on
glycaemic control in patients with T1D inadequately controlled by
insulin. All patients will be evaluated at week 24 and after a
28-week extension (52 weeks in total).

About Forxiga (dapagliflozin)

Forxiga is a first-in-class selective inhibitor of human SGLT2
indicated as both monotherapy and as part of combination therapy to
improve glycaemic control. Although not indicated for these uses,
Forxiga provides the added benefits of blood pressure reductions and
weight loss in adult patients with type-2 diabetes (T2D).

AstraZeneca continues to push the boundaries of science with Forxiga
through the largest and broadest patient-centric clinical programme.
The DapaCare clinical programme will enrol nearly 30,000 patients in
randomised clinical trials, include a wide range of mechanistic
studies, and is supported by a multinational real-world evidence
study (CVD-REAL). DapaCare and complimentary clinical research will
generate first-in-class data for Forxiga across a spectrum of people
with T2D, T1D, established CV disease, CV risk factors and varying
stages of renal disease, both with and without T2D, providing
healthcare providers with evidence needed to improve patient
outcomes. DapaCare underscores our commitment to following the
science with Forxiga, as the first SGLT2 inhibitor to be tested in
these diverse patient populations, pursuing a holistic patient
approach to address the multiple risk factors associated with CV,
metabolic and renal diseases.

About AstraZeneca in Cardiovascular, Renal & Metabolism (CVRM)

Cardiovascular, renal and metabolic diseases together form one of
AstraZeneca's main therapy areas and platforms for future growth. By
following the science to understand more clearly the underlying links
between the heart, kidney 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. Our ambition is to modify or halt the natural course
of CVRM diseases and even 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 & Metabolism
and Respiratory. The Company also is selectively active in the areas
of autoimmunity, neuroscience and infection. 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 and follow us
on Twitter @AstraZeneca.

Media Relations
Gonzalo Viña UK/Global +44 203 749 5916
Rob Skelding UK/Global +44 203 749 5821
Matt Kent UK/Global +44 203 749 5906
Karen Birmingham UK/Global +44 203 749 5634
Jacob Lund Sweden +46 8 553 260 20
Michele Meixell US +1 302 885 2677

Investor Relations
Thomas Kudsk Larsen +44 203 749 5712
Craig Marks Finance; Fixed Income; M&A +44 7881 615 764
Henry Wheeler Oncology +44 203 749 5797
Mitchell Chan Oncology; Other +1 240 477 3771
Christer Gruvris Brilinta; Diabetes +44 203 749 5711
Nick Stone Respiratory; Renal +44 203 749 5716
US toll free +1 866 381 7277

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