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 June
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.
Bydureon
receives positive CHMP opinion for BCise
29 June 2018 15:00 BST
Bydureon receives positive
EU CHMP opinion for new BCise device for
patients with type-2 diabetes
New formulation of once-weekly Bydureon in a pre-filled device
recommended to
help improve glycaemic control
AstraZeneca today announced that the Committee for Medicinal
Products for Human Use (CHMP) of the European Medicines Agency
(EMA) has adopted a positive opinion, recommending inclusion
of Bydureon (2mg prolonged-release suspension for
injection) BCise device as a new formulation within the marketing
authorisation for Bydureon (exenatide extended-release) for the treatment of
type-2 diabetes.
The new formulation of once-weekly Bydureon is an improved single-dose,
pre-filled pen device which, in combination with other
glucose-lowering medicines including basal insulin, aims 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.
The
CHMP recommendation is based on the 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 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 administered once weekly via the
BCise
device 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.
This new formulation of once-weekly Bydureon (2mg prolonged-release suspension for injection)
for the BCise device is approved
by the US FDA.
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:
29 June
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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