a4505d
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 2020
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
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by check mark whether the registrant files or will file annual
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
Forxiga cardiovascular
outcomes benefit approved in China
28 October 2020 07:00 GMT
Forxiga cardiovascular outcomes benefit approved in
China
Update to approval includes DECLARE-TIMI 58 Phase III trial that
reduced the risk
of composite of hospitalisation for heart failure or cardiovascular
death in type-2 diabetes
China's National Medical Products Administration (NMPA) has updated
the label for AstraZeneca's Forxiga (dapagliflozin) to include data from the
DECLARE-TIMI 58 Phase III trial.
DECLARE-TIMI 58 demonstrated that Forxiga achieved a statistically significant
reduction in the composite endpoint of hospitalisation for heart
failure (hHF) or cardiovascular (CV) death, versus placebo, in
adults with type-2 diabetes (T2D) and established CV disease or
multiple CV risk factors. The trial confirmed the well-established
safety profile of Forxiga.1
DECLARE-TIMI 58 is the largest sodium-glucose cotransporter 2
(SGLT2) inhibitor CV outcomes trial conducted to date, and data
from the trial were published in The
New England Journal of Medicine in January 2019.
There are an estimated 463 million people living with diabetes
worldwide, with nearly 120 million in
China.2 Patients
with T2D are two to five times more likely to develop chronic heart
failure (HF) than those without T2D.3
Ruud Dobber, Executive Vice President, BioPharmaceuticals Business
Unit, said: "Heart failure is one of the first cardiovascular
complications for patients with type-2 diabetes. The DECLARE-TIMI
58 Phase III data show that Forxiga reduces the risk of hospitalisation for
heart failure and, with this label update, we look forward to
bringing this significant benefit to patients in
China."
Forxiga is indicated as a
monotherapy and as part of combination therapies to improve
glycaemic control in adults with T2D. The NMPA label update, based
on the DECLARE-TIMI 58 Phase III data, follows the update to the EU
marketing authorisation in August
2019 and the approval by
the US Food and Drug Administration (FDA)
in October
2019 of an indication
for Forxiga (known
as Farxiga in the US) to reduce the risk of hHF in
adults with T2D and established CV disease or multiple CV risk
factors.
In May
2020, Farxiga was approved in the US to reduce the risk of
CV death and hHF in adults with HF (NYHA class II-IV) with reduced
ejection fraction (HFrEF) with and without T2D, and
in October
2020 Forxiga was recommended for approval for
HF in the EU by the Committee for Medicinal Products for Human Use.
Additionally, the FDA granted Farxiga Breakthrough Therapy Designation
in October
2020 to
accelerate the development and regulatory review for patients
with chronic kidney disease (CKD), with and without
T2D.
Type-2 diabetes
T2D is a chronic disease characterised by pathophysiologic defects
leading to elevated glucose levels, or
hyperglycaemia.2 Over
time, this sustained hyperglycaemia contributes to further
progression of the disease.2 The
prevalence of diabetes is projected to reach 578 million people
worldwide by 2030, and 700 million by 2045.2 T2D
accounts for approximately 90-95 percent of all cases of diagnosed
diabetes.4
DECLARE-TIMI 58
DECLARE-TIMI 58 is an AstraZeneca-sponsored, Phase III, randomised,
double-blinded, placebo-controlled, multicentre trial designed to
evaluate the effect of Forxiga compared with placebo on CV outcomes in
adults with T2D at risk of CV events, including patients with
multiple CV risk factors or established CV disease, and also
assessed key renal secondary endpoints. The trial included more
than 17,000 patients across 882 sites in 33 countries and was
independently run in collaboration with academic investigators from
the TIMI study group (Boston, US) and the Hadassah Hebrew
University Medical Center (Jerusalem, Israel).1
Forxiga
Forxiga (dapagliflozin) is
a first-in-class, oral, once-daily SGLT2 inhibitor indicated in
adults for the treatment of insufficiently controlled T2D as both
monotherapy and as part of combination therapy as an adjunct to
diet and exercise to improve glycaemic control, with the additional
benefits of weight loss and blood-pressure
reduction.
Forxiga has been evaluated
in patients with CKD in the Phase III DAPA-CKD trial, with the full
results announced in August
2020 demonstrating
that Forxiga met all primary and secondary endpoints,
providing overwhelming efficacy. Forxiga is currently being tested for patients with
HF in the DELIVER (HF with preserved ejection fraction, HFpEF) and
DETERMINE (HFrEF and HFpEF) Phase III
trials. Forxiga will also be tested in patients without T2D
following an acute myocardial infarction (MI) or heart attack in
the DAPA-MI trial - a first of its kind, indication-seeking
registry-based randomised controlled
trial. Forxiga has
a robust programme of clinical trials that includes more than 35
completed and ongoing Phase IIb/III trials in more than 35,000
patients, as well as more than 2.5 million patient-years'
experience.
AstraZeneca in CVRM
Cardiovascular, Renal and 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 comorbidities. 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.
AstraZeneca
AstraZeneca (LSE/STO/Nasdaq: AZN) 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 & Immunology. Based in Cambridge, UK, AstraZeneca
operates in over 100 countries and its innovative medicines are
used by millions of patients worldwide. Please
visit astrazeneca.com and
follow the Company on Twitter @AstraZeneca.
Contacts
For details on how to contact the Investor Relations Team, please
click here.
For Media contacts, click here.
References
1. Wiviott SD et al. Dapagliflozin and
Cardiovascular Outcomes in Type 2
Diabetes. N
Engl J Med 2019;
380(4):347-57.
2. International
Diabetes Federation. IDF Diabetes Atlas Ninth Edition 2019.
Available from: URL: https://diabetesatlas.org/upload/resources/material/20200302_133351_IDFATLAS9e-final-web.pdf (Accessed
25 October 2020).
3. Ofstad AP et al. The heart failure
burden of type 2 diabetes mellitus-a review of pathophysiology and
interventions. Heart Fail
Rev 2018;
23(3):303-23.
4. Centers for
Disease Control and Prevention (CDC). Diabetes Fast Facts.
Available from: URL: https://www.cdc.gov/diabetes/basics/quick-facts.html (Accessed
25 October 2020).
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:
28 October
2020
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By: /s/
Adrian Kemp
|
|
Name:
Adrian Kemp
|
|
Title:
Company Secretary
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