Blueprint
FORM 6-K
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
Report
of Foreign Issuer
Pursuant
to Rule 13a-16 or 15d-16 of
the
Securities Exchange Act of 1934
For the
month of May
2018
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
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by check mark whether the registrant files or will file annual
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by check mark whether the registrant by furnishing the information
contained in this Form is also thereby furnishing the information
to the Commission pursuant to Rule 12g3-2(b) under the Securities
Exchange Act of 1934.
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assigned to the Registrant in connection with Rule 12g3-2(b):
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
AZ
regulatory submission in Japan for Forxiga
21 May 2018 07:00 BST
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.
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Adrian Kemp
Company Secretary
AstraZeneca PLC
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized.
Date:
21 May
2018
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By: /s/
Adrian Kemp
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Name:
Adrian Kemp
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Title:
Company Secretary
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