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 October
2017
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
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82-_____________
23 October 2017 07:00 BST
US FDA APPROVES NEW EASY-TO-USE, ONCE-WEEKLY BYDUREON BCISE INJECTABLE MEDICINE FOR PATIENTS
WITH TYPE-2 DIABETES
New formulation of once-weekly exenatide in an improved device
provides significant HbA1c reduction with added benefit of weight
loss
AstraZeneca today
announced that the US Food and Drug Administration (FDA) has
approved Bydureon
BCise (exenatide
extended-release) injectable suspension, a new formulation of
Bydureon in an improved
once-weekly, single-dose autoinjector device for adults with type-2
diabetes whose blood sugar remains uncontrolled on one or more oral
medicines in addition to diet and exercise, to improve glycaemic
control.
Unlike other glucagon-like peptide-1 (GLP-1) receptor
agonists, Bydureon BCise
has a unique, continuous-release
microsphere delivery system designed to provide consistent
therapeutic levels of the active ingredient, exenatide, to help
patients reach and maintain steady state. The new formulation in
the innovative Bydureon BCise device is proven to reduce blood sugar levels,
with the added benefit of weight loss.
Across
two clinical trials, average HbA1c reductions of up to 1.4% and
average weight loss of up to 3.1 pounds (1.4 kilograms) were
achieved when used as monotherapy or as an add-on to metformin, a
sulfonylurea, a thiazolidinedione, or any combination of two of
these oral anti-diabetic medicines at 28 weeks. The most common
adverse reactions reported in ≥5% of patients in clinical
trials were nausea (8.2%) and adverse events associated with
injection-site nodules (10.5%).
Ruud Dobber, President, AstraZeneca US and Executive Vice
President, North America, said: "We know that physicians have
established long-standing confidence in the significant HbA1c
reduction Bydureon provides their patients to help achieve
consistent control, with the added benefit of weight loss. With the
approval of Bydureon
BCise, we're now introducing a
new formulation in an improved, easy-to-use device that will help
enhance the patient experience."
Bydureon BCise will be available for patients in
the US in the first quarter of 2018. A regulatory application for
the new autoinjector device has also been accepted by the European
Medicines Agency.
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, Renal & Metabolic Diseases
(CVMD)
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 CVMDs and even regenerate organs and restore
function, by continuing to deliver transformative science that
improves treatment practices and CVMD 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 & 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.
Date:
23 October 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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