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 August
2018
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
EC
approves Bydureon BCise device for T2 diabetes
30 August 2018 07:00 BST
European Commission approves new
easy-to-use, once-weekly Bydureon
BCise device for patients
with type-2 diabetes
AstraZeneca today announced that the European Commission (EC) has
approved Bydureon
BCise (exenatide 2mg
prolonged-release suspension for injection in pre-filled
pen) as a new formulation within the marketing
authorisation for Bydureon (exenatide extended release) for the
treatment of patients with type-2 diabetes.
The new formulation of once-weekly Bydureon is an improved
single-dose, pre-filled pen device that requires no titration and
is approved for use in combination with other glucose-lowering
medicines, including basal insulin, to help improve glycaemic
control in adults with type-2 diabetes whose blood sugar levels are
inadequately controlled by other glucose-lowering medicines
together with diet and exercise.
This approval is supported by data from two clinical trials,
DURATION-NEO-1 and NEO-2. DURATION-NEO-1 is a 28-week, randomised,
open-label, comparator-controlled trial (n=375), which showed that
once-weekly Bydureon
BCise demonstrated an
HbA1c reduction of 1.4% vs. 1.0% for
twice-daily Byetta (exenatide) injection at 28 weeks (baseline
HbA1c 8.5% and 8.4%, respectively).
Additionally, Bydureon BCise demonstrated a mean weight reduction of -1.5
Kg as monotherapy vs. -1.9 Kg (baseline was 97 Kg) when combined
with certain oral antidiabetic medicines.
Elisabeth Björk, Vice President, Head of Cardiovascular, Renal
and Metabolism, Global Medicines Development at AstraZeneca, said:
"Building on the already well-established efficacy and safety
profile of once-weekly Bydureon, today's approval of Bydureon
BCise will enable us to
offer an additional treatment option for patients with type-2
diabetes whose blood sugar levels are inadequately controlled by
other glucose-lowering medicines together with diet and
exercise."
This new formulation of once-weekly Bydureon BCise was approved by
the US Food and Drug Administration (FDA) in October
2017.
About AstraZeneca in Cardiovascular,
Renal & Metabolism (CVRM)
Cardiovascular, renal and metabolism together forms one of
AstraZeneca's main therapy areas and key
growth drivers. By
following the science to understand more clearly the underlying
links between the heart, kidneys 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 potentially 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. 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
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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:
30 August
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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