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2019-10-21

AstraZeneca: Farxiga approved in the US to reduce the risk of hospitalisation for heart failure in patients with type-2 dia...

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
(https://www.nejm.org/doi/full/10.1056/NEJMoa1911303) 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 the Phase 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
(https://www.astrazeneca.com/media-centre/press-releases/2018/farxiga-sig...)
trial were published in The New England Journal of Medicine
(https://www.nejm.org/doi/full/10.1056/NEJMoa1812389) 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
(http://www.astrazeneca.com/) and follow us on Twitter @AstraZeneca
(https://clicktime.symantec.com/37Bg16U1oCzfevsztvEsc5x6H2?u=https%3A%2F%...).

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