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 May 2020
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.
Farxiga approved
in the US for the treatment of heart failure
in patients with heart failure with reduced ejection
fraction
6 May 2020 07:00 BST
Farxiga approved in the US for the treatment of
heart failure
in patients with heart failure with reduced ejection
fraction
Farxiga is the first SGLT2 inhibitor proven to significantly
reduce
the risk of cardiovascular death and hospitalisation for heart
failure
AstraZeneca's Farxiga (dapagliflozin) has been approved in the US
to reduce the risk of cardiovascular (CV) death and hospitalisation
for heart failure in adults with heart failure (NYHA class II-IV)
with reduced ejection fraction (HFrEF) with and without type-2
diabetes (T2D).
The approval by the Food and Drug Administration (FDA) was based on
positive results from the landmark Phase III DAPA-HF
trial, which showed Farxiga achieving a statistically significant and
clinically meaningful reduction of CV death or hospitalisation for
heart failure (HF), compared to placebo. The decision follows the Priority Review
designation granted by the
FDA earlier this year and the Fast Track
designation granted in
September 2019.
Farxiga is the first
sodium glucose co-transporter 2 (SGLT2) inhibitor approved by the
US FDA indicated to treat patients with HFrEF (LVEF ≤
40%).
Mene Pangalos, Executive Vice President, BioPharmaceuticals
R&D, said: "With the approval of Farxiga, we have reached a critical milestone to
potentially transform heart failure treatment for the millions of
people living with the condition in the US. We are now one step closer to making a
significant impact on their lives by providing a much-needed
treatment to help reduce their disease burden and live
longer."
John McMurray, MD, Cardiovascular Research Centre, Institute of
Cardiovascular and Medical Sciences, University of Glasgow, UK,
said: "The ground-breaking results of the DAPA-HF trial have
transformed heart failure therapeutics. Today's approval provides
physicians with a completely novel pharmacological approach that
greatly improves outcomes for patients with heart failure with
reduced ejection fraction."
The DAPA-HF trial showed that Farxiga, in addition to standard of care, reduced the
risk of the composite outcome of CV death or the worsening of HF
versus placebo by 26% (absolute risk reduction [ARR] = 5%
[event rate/100 patient years: 11.6 vs 15.6, respectively];
p<0.0001) in patients with HFrEF. During the trial
duration, one CV death or hospitalisation for HF or an urgent
visit associated with HF could be avoided for every 21 patients
treated with Farxiga.
The safety profile of Farxiga in the DAPA-HF trial was consistent with the
well-established safety profile of the medicine. The data from
the DAPA-HF trial were published in The
New England Journal of Medicine.1
In October 2019 the US FDA approved Farxiga to
reduce the risk of hospitalisation for HF in adult patients with
T2D and established CV disease or multiple CV risk factors. The
approval was based on the DECLARE-TIMI 58
trial.
Farxiga is also indicated
as an adjunct to diet and exercise to improve glycaemic control in
adults with T2D.
Heart failure
HF is a life-threatening disease in which the heart cannot pump
enough blood around the body.2 It
affects approximately 64 million people worldwide (at least half of
which have a reduced ejection fraction) and six million in the
US.3-5 It
is a chronic disease where half of patients will die within five
years of diagnosis.6 There
are two main categories of HF related to ejection fraction (EF), a
measurement of the percentage of blood leaving the heart each time
it contracts: HFrEF and heart failure with preserved ejection
fraction (HFpEF).7 HFrEF
occurs when the left ventricle (LV) muscle is not able to contract
adequately and therefore, expels less oxygen-rich blood in to the
body.7,
8 HF remains as fatal as
some of the most common cancers in both men (prostate and bladder
cancers) and women (breast cancer).9 It
is the leading cause of hospitalisation for those over the age of
65 and represents a significant clinical and economic
burden.10
DAPA-HF
DAPA-HF (Dapagliflozin And Prevention of Adverse-outcomes in Heart
Failure) is an international, multi-centre, parallel-group,
randomised, double-blinded trial in 4,744 patients with heart
failure and reduced ejection fraction (LVEF ≤ 40%), with and
without T2D, designed to evaluate the effect
of Farxiga 10mg,
compared with placebo, given once daily in addition to standard of
care. The primary composite endpoint was time to the first
occurrence of a worsening heart failure event (hospitalisation or
equivalent event; i.e. an urgent heart failure visit), or
cardiovascular death. The median duration of follow-up was 18.2
months.1
Farxiga
Farxiga (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. In the
DECLARE CV outcomes trial in adults with
T2D, Farxiga reduced the risk of the composite endpoint
of hospitalisation for HF or CV death versus placebo, when added to
standard of care.11
Farxiga is currently also
being evaluated for patients with chronic kidney disease (CKD) in
the Phase III DAPA-CKD
trial, which has been stopped
early after a Data Monitoring Committee determination of
overwhelming efficacy. The FDA has
granted Fast Track
designation for the
development of Farxiga in CKD.
Additionally, Farxiga is also being tested for patients with HF in
the DELIVER (HFpEF) and DETERMINE function and symptom (HFrEF and
HFpEF) trials. 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.
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/NYSE: 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 and Metabolism, and Respiratory.
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. McMurray JJV et al. Dapagliflozin in Patients with Heart Failure
and Reduced Ejection Fraction. N Engl J
Med 2019.
2. Mayo Clinic. Heart failure; 2017 [cited 2019 Aug 14]. Available
from: URL:
https://www.mayoclinic.org/diseases-conditions/heart-failure/symptoms-causes/syc-20373142.
3. Virani SS et al. Heart Disease and Stroke Statistics-2020
Update: A Report From the American Heart
Association. Circulation 2020; 141(9):e139-e596.
4. Bhuiyan T, Maurer MS. Heart Failure with Preserved Ejection
Fraction: Persistent Diagnosis, Therapeutic
Enigma. Curr Cardiovasc Risk
Rep 2011;
5(5):440-9.
5. Vos T et al. Global, regional, and national incidence,
prevalence, and years lived with disability for 328 diseases and
injuries for 195 countries, 1990-2016: A systematic analysis for
the Global Burden of Disease Study 2016. The Lancet 2017;
390(10100):1211-59.
6. Mozaffarian D et al. Circulation. 2016 Jan 26;133(4):e38-360 and the CDC:
https://www.cdc.gov/dhdsp/data_statistics/fact_sheets/fs_heart_failure.htm.
7. Ponikowski P et al. 2016 ESC Guidelines for the diagnosis and
treatment of acute and chronic heart failure: The Task Force for
the diagnosis and treatment of acute and chronic heart failure of
the European Society of Cardiology (ESC)Developed with the special
contribution of the Heart Failure Association (HFA) of the
ESC. Eur Heart J 2016; 37(27):2129-200.
8. National Institute for Health and Care Excellence. Chronic heart
failure in adults: diagnosis and management: NICE guideline
[NG106]; 2018 [cited 2020 Apr 02]. Available from: URL:
www.nice.org.uk/guidance/ng106.
9. Mamas MA et al. Do patients have worse outcomes in heart failure
than in cancer? A primary care-based cohort study with 10-year
follow-up in Scotland. Eur J Heart
Fail 2017;
19(9):1095-104.
10. Azad N, Lemay G. Management of chronic heart failure in the
older population. J Geriatr
Cardiol 2014;
11(4):329-37.
11. Wiviott SD et al. Dapagliflozin and Cardiovascular Outcomes in
Type 2 Diabetes. N Engl J
Med 2019;
380(4):347-57.
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:
06 May
2020
|
By: /s/
Adrian Kemp
|
|
Name:
Adrian Kemp
|
|
Title:
Company Secretary
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