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2018-09-25

AstraZeneca: Bydureon receives positive EU CHMP opinion for EXSCEL cardiovascular outcomes data

Label now includes data that demonstrated favourable cardiovascular
safety profile for patients with type-2 diabetes at wide range of
cardiovascular risk

AstraZeneca today announced that the Committee for Medicinal Products
for Human Use (CHMP) of the European Medicines Agency (EMA) has
adopted a positive opinion on a Type-II variation update for Bydureon
(exenatide extended-release), to include in the European label
cardiovascular (CV) data from the EXSCEL (EXenatide Study of
Cardiovascular Event Lowering) trial in adults with type-2 diabetes
at a wide range of CV risk.

In EXSCEL, Bydureon did not increase the incidence of major adverse
cardiovascular events (MACE), a composite endpoint of CV death,
non-fatal heart attack (myocardial infarction) or non-fatal stroke,
compared to placebo (Hazard Ratio [HR]: 0.91; 95% Confidence Interval
[CI]: 0.83-1.00; p<0.001 for non-inferiority). Although the primary
efficacy objective of a superior reduction in MACE narrowly missed
statistical significance (p=0.061), there were fewer CV events
observed in the Bydureon arm of the trial (839 [11.4%] versus 905
[12.2%]). The prespecified secondary analysis on all-cause mortality
has also been accepted for inclusion in the European label. Patients
on Bydureon had a 14% lower incidence of all-cause mortality compared
to usual care alone (HR: 0.86; 95% CI: 0.77-0.97).

Elisabeth Björk, Vice President, Head of Cardiovascular, Renal and
Metabolic Diseases, Global Medicines Development at AstraZeneca said:
"We are pleased with this positive recommendation for Bydureon and
what it means for patients with type-2 diabetes with a wide range of
cardiovascular risk. Our pursuit of this label is based on our strong
belief in the clinical value the EXSCEL data brings to physicians and
patients."

The full results of EXSCEL
(https://www.astrazeneca.com/media-centre/press-releases/2017/bydureon-ex...)
have been published in the New England Journal of Medicine
(http://www.nejm.org/doi/full/10.1056/NEJMoa1612917).

ENDS

NOTES FOR EDITORS

The positive CHMP opinion to include cardiovascular data from the
EXSCEL trial in the European label for Bydureon can be implemented
without the need for an immediate European Commission decision due to
the nature of the amendment, which is a Type-II variation.

About EXSCEL

EXSCEL is a Phase IIIb/IV, double-blinded, placebo-controlled, global
CV outcomes trial conducted in 35 countries and enrolled 14,500
patients with type-2 diabetes with or without additional CV risk
factors or prior CV events. Overall, 73% of included patients had
experienced at least one prior CV event, whereas 27% had not.
Participants were randomised to receive exenatide 2mg once-weekly 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 Cardiovascular, Renal & Metabolism (CVRM)

Cardiovascular, renal and metabolism together form one of
AstraZeneca's main therapy areas and a key growth driver for the
Company. 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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