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 2017
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
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This announcement contains inside information
23 May
2017 07:00 BST
BYDUREON
EXSCEL TRIAL MEETS PRIMARY SAFETY OBJECTIVE IN
TYPE-2 DIABETES PATIENTS AT WIDE RANGE OF CARDIOVASCULAR
RISK
Based on a composite measure of major adverse CV events (MACE),
Bydureon did not increase cardiovascular (CV) risk and showed a
consistent safety profile
Fewer CV events were observed in the Bydureon arm, however, the
efficacy objective of reduction in CV risk did not reach
statistical significance
AstraZeneca
today announced top-line results from the Phase IIIb/IV
EXSCEL ( EXenatide Study of Cardiovascular Event Lowering) trial . The trial
compared the effect of once-weekly Bydureon(exenatide
extended-release) versus placebo, when added to usual type-2
diabetes care, on the risk of MACE, a composite endpoint of CV
death, non-fatal myocardial infarction or non-fatal stroke , in
adults with type-2 diabetes (T2D) at a wide range of CV
risk.
The
EXSCEL trial met its primary safety objective of non-inferiority
for MACE. These results address the US Food and Drug Administration
(FDA) requirement that medicines to treat T2D are not associated
with an increase in CV risk. Fewer CV events were observed in the
Bydureonarm of the trial, however, the efficacy objective of a
superior reduction in MACE did not reach statistical significance.
Data were consistent with the known safety profile of Bydureon.
Elisabeth
Björk, Vice President, Head of Cardiovascular and Metabolic
Diseases, Global Medicines Development, AstraZeneca, said: "These
top-line results from the EXSCEL trial provide robust evidence of
the cardiovascular safety profile of Bydureonacross a wide range of patients
with type-2 diabetes. Furthermore, the trial design and broad
inclusion criteria of EXSCEL offer physicians relevant data
applicable to clinical practice."
The
EXSCEL trial is the largest and most inclusive patient population
of any CV outcomes trial of the glucagon-like peptide-1 (GLP-1)
receptor agonist class conducted to date, having included more than
14,000 patients from 35 countries.
A full
evaluation of the EXSCEL data is ongoing. The results will be
presented at the European Association for the Study of Diabetes
(EASD) annual meeting on Thursday, 14 September 2017 in Lisbon,
Portugal.
About EXSCEL
EXSCEL
is a Phase IIIb/IV, double-blind, placebo-controlled, global CV
outcomes trial conducted in 35 countries and enrolled more than
14,000 patients with type-2 diabetes with or
without additional CV risk factors or prior CV events. Participants
were randomised to receive exenatide once-weekly 2mg or matching
placebo by subcutaneous injections. EXSCEL was run jointly by two
academic research organisations - the Duke Clinical Research
Institute (Durham, NC, US) and the University of Oxford Diabetes
Trials Unit (Oxford, UK).
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. As a main 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, 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 products to help more patients achieve treatment
success earlier in their disease.
About AstraZeneca in Cardiovascular & Metabolic Diseases
(CVMD)
Cardiovascular,
renal and metabolic diseases are key areas of focus for AstraZeneca
as part of the company's strategy for achieving scientific
leadership and returning to growth. By collaborating across
therapeutic disciplines within the CVMD therapy area, we are
addressing the underlying disorders that drive CVMD risk, with the
goal of reducing morbidity, mortality and organ damage through
innovative therapies. Recognising the growing unmet needs and
challenges faced by the millions of people worldwide living with
these interrelated diseases, we are determined to understand how
they interact and impact one another - and how they can be treated
together to save more patients' lives.
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 main
therapy areas - Oncology, Cardiovascular & Metabolic Diseases
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.
AstraZeneca
PLC
Date:
22 May 2017
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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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