AstraZeneca PLC Farxiga approved in the US to reduce the risk of (5063Q)
21 Ottobre 2019 - 8:00AM
UK Regulatory
TIDMAZN
RNS Number : 5063Q
AstraZeneca PLC
21 October 2019
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 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 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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