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 July
2019
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.
Update
on US regulatory decision for Farxiga
15 July 2019 07:00 BST
Update on US regulatory decision
for Farxiga in type-1 diabetes
AstraZeneca today announced that the US Food and Drug
Administration (FDA) has issued a complete response letter
regarding the supplemental New Drug Application
for Farxiga(dapagliflozin) as an adjunct treatment
to insulin to improve glycaemic control in adult patients with
type-1 diabetes (T1D), when insulin alone does not provide
adequate glycaemic control.
AstraZeneca will work closely with the FDA to discuss the next
steps.
Farxiga was recently
approved in Europe (5mg) and Japan (5mg, potential up-titration to
10mg) under the name Forxiga, as an adjunct to insulin in adults with
T1D.
About Farxiga
Farxiga (dapagliflozin) is a first-in-class, oral, once-daily selective
inhibitor of SGLT2 indicated as both monotherapy and as part of
combination therapy to improve glycaemic control, with the
additional benefits of weight loss and blood-pressure reduction, as
an adjunct to diet and exercise in adults with
T2D. Farxiga has a robust clinical trial programme of
more than 35 completed and ongoing Phase IIb/III trials with over
35,000 patients, as well as more than 1.8 million patient-years'
experience.
About DEPICT
The DEPICT (Dapagliflozin Evaluation in Patients with Inadequately Controlled Type-1 diabetes) clinical trial programme
consists of two clinical trials, DEPICT-1 (NCT02268214) and
DEPICT-2 (NCT02460978), which are 24-week, randomised,
double-blinded, parallel-controlled trials designed to assess the
effects of Farxiga 5mg or 10mg on glycaemic control in patients
with T1D, inadequately controlled by insulin. All patients were
evaluated at week 24 and after a 28-week extension (52 weeks in
total).
About type-1 diabetes
T1D is a chronic disease in which the pancreas produces little or
no insulin. Approximately five per cent of people living with
diabetes have type-1. The condition is caused by an autoimmune
reaction that destroys the beta cells in the pancreas which produce
insulin.1 Different
factors, including genetics and some viruses, may contribute to
T1D.2
About AstraZeneca in CVRM
Cardiovascular, Renal & Metabolism (CVRM) together forms one of
AstraZeneca's three therapy areas and is 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. The Company's 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 astrazeneca.com and
follow us on Twitter @AstraZeneca.
Media
Relations
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Adrian Kemp
Company Secretary
AstraZeneca PLC
References
1.
"Diabetes Home." Centers for Disease Control and Prevention,
Centers for Disease Control and Prevention, 15 Aug. 2018,
www.cdc.gov/diabetes/basics/type1.html.
2.
Type 1 Diabetes." Mayo Clinic, Mayo Foundation for Medical
Education and Research, 7 Aug. 2017,
www.mayoclinic.org/diseases-conditions/type-1-diabetes/symptoms-causes/syc-20353011.
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:
15 July
2019
|
By: /s/
Adrian Kemp
|
|
Name:
Adrian Kemp
|
|
Title:
Company Secretary
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