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2018-08-30

AstraZeneca: European Commission approves new easy-to-use, once-weekly Bydureon BCise device for patients with type-2 diab...

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
(https://www.astrazeneca.com/media-centre/press-releases/2017/us-fda-appr...)
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.

Media Relations
Karen Birmingham UK/Global +44 203 749 5634
Rob Skelding UK/Global +44 203 749 5821
Matt Kent UK/Global +44 203 749 5906
Gonzalo Viña UK/Global +44 203 749 5916
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Investor Relations
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