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 October
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
Farxiga approved in the US to reduce the risk
of hospitalisation
for heart failure in patients with type-2
diabetes
21 October 2019 07:00 BST
Farxiga approved in the US to reduce the risk
of hospitalisation
for heart failure in patients with type-2 diabetes
AstraZeneca today announced that the US Food and Drug
Administration (FDA) has approved Farxiga (dapagliflozin) to reduce the risk
of hospitalisation for heart failure (hHF) in adults with
type-2 diabetes (T2D) and established cardiovascular disease
(CVD) or multiple cardiovascular (CV) risk
factors.
The approval is based on results from the landmark DECLARE-TIMI 58
CV outcomes trial (CVOT),the largest sodium-glucose
cotransporter 2 (SGLT2) inhibitor CVOT conducted to date to
evaluate T2D patients with multiple CV risk factors or established
CV disease.
Ruud Dobber, Executive Vice President, BioPharmaceuticals Business
Unit, said: "Farxiga is the first SGLT2 inhibitor approved in the
US to reduce the risk of hospitalisation for heart failure in
type-2 diabetes patients with established cardiovascular disease or
multiple cardiovascular risk factors. This is promising news for
the 30 million people living with type-2 diabetes in the US, as
heart failure is one of the earliest cardiovascular complications
for them, before heart attack or stroke. Farxiga now offers the opportunity for physicians to
act sooner and reduce the risk of hospitalisation for heart
failure."
Dr. Stephen Wiviott of Brigham and Women's Hospital and Harvard
Medical School, Boston, US and a Senior Investigator with the TIMI
study group and co-principal investigator of the trial, said:
"DECLARE-TIMI 58 is a landmark trial, offering compelling evidence
that dapagliflozin can reduce the risk of heart failure in patients
living with type-2 diabetes with multiple risk factors for or
established cardiovascular disease. These data could help change
the way we approach diabetes management - going beyond a singular
focus on glucose control to help address the risk of heart failure
in a diverse population of patients."
Today's US FDA approval follows the update to the marketing
authorisation in the EU in August 2019. Farxiga is also under regulatory review in China
with a decision anticipated in the first half of
2020.
The US FDA has granted Fast Track designation
for Farxiga to reduce the risk of CV death, or the
worsening of heart failure in adults with heart failure with
reduced ejection fraction (HFrEF) or preserved ejection fraction
(HFpEF) based on the Phase III DAPA-HF and
DELIVER trials, and Fast Track designation to delay the progression
of renal failure and prevent CV and renal death in patients with
chronic kidney disease (CKD) based on thePhase III DAPA-CKD
trial.
About Farxiga
Farxiga is a
first-in-class, oral once-daily SGLT2 inhibitor 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 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.
About DECLARE-TIMI 58
DECLARE (Dapagliflozin Effect on Cardiovascular Events)-TIMI 58 is
the largest CV outcomes trial conducted for a selective inhibitor
of SGLT2 to date in a broad patient population. It is an
AstraZeneca-sponsored, Phase III, randomised, double-blind,
placebo-controlled, multicentre trial designed to evaluate the
effect of Farxiga 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).
DECLARE-TIMI 58 showed that Farxiga significantly reduced the risk of the
primary composite endpoint of hHF or CV death versus placebo
by 17% (4.9% vs. 5.8%; HR 0.83 [95% CI 0.73-0.95], p=0.005). This
finding was driven by a significant 27% reduction in the risk of
hHF (2.5% vs. 3.3%; HR 0.73 [95% CI 0.61, 0.88]). The treatment
benefit was consistent across patient subgroups. The Phase III
DECLARE-TIMI 58 trial confirmed the well-established safety profile
of Farxiga.
The full results of the DECLARE-TIMI
58 trial were published
in The
New England Journal of Medicine in January 2019.
About AstraZeneca in Cardiovascular, Renal and
Metabolism
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.
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 and
Metabolism (CVRM), 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.
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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:
21 October
2019
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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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