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 November 2020
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
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United
Kingdom
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
Forxiga approved in the EU for heart failure
5 November 2020 07:05 GMT
Forxiga approved in the EU for heart
failure
Forxiga is the first SGLT2 inhibitor approved in the EU for heart
failure
with reduced ejection fraction in adult patients with and without
type-2 diabetes
AstraZeneca's Forxiga (dapagliflozin) has been approved in the
European Union (EU) for the treatment of symptomatic chronic heart
failure with reduced ejection fraction (HFrEF) in adults with and
without type-2 diabetes (T2D).
Heart failure (HF) is a life-threatening chronic disease that
prevents the heart from pumping sufficient levels of blood around
the body. It affects 15 million people in the EU, at least half of
whom have a reduced ejection fraction,1-3 which
occurs when the left ventricle muscle is not able to contract
adequately and therefore expels less oxygen-rich blood into the
body.4-6
The approval by the European Commission is based on positive
results from the landmark DAPA-HF Phase III trial, published
in The
New England Journal of Medicine.7 It
follows the recommendation for
approval by the Committee
for Medicinal Products for Human Use of the European Medicines
Agency.
John McMurray, MD, Cardiovascular Research Centre, Institute of
Cardiovascular and Medical Sciences, University of Glasgow, UK,
said: "Today's approval provides physicians with a completely novel
treatment for heart failure with reduced ejection fraction, not
only improving symptoms and reducing hospital admissions, but also
increasing survival in this life-threatening
condition."
Mene Pangalos, Executive Vice President, BioPharmaceuticals
R&D, said: "With this approval of Forxiga, we can redefine the standard of care for
millions of people in the EU living with heart failure. We are
another step closer to achieving our ambition of preventing or
treating heart failure by providing a treatment that can
significantly reduce cardiovascular death and
hospitalisation."
Forxiga is the first
sodium-glucose co-transporter-2 (SGLT2) inhibitor to have shown a
statistically significant reduction in the risk of the composite of
cardiovascular (CV) death or worsening of HF events, including
hospitalisation for HF (hHF). The DAPA-HF Phase III trial
demonstrated that Forxiga, in addition to standard of care, reduced the
risk of the composite outcome versus placebo by 26% and both
components of the primary composite endpoint contributed benefit to
the overall effect. In the DAPA-HF Phase III trial, the safety
profile of Forxiga was consistent with the well-established
safety profile of the medicine. During the trial, one CV death or
hHF or an urgent visit associated with HF could be avoided for
every 21 patients treated.
Forxiga (known
as Farxiga in the US) is approved in the US for the
treatment of patients with HFrEF and is currently under review in
Japan and in several over countries around the
world.
Forxiga is advancing
cardiorenal prevention as science continues to identify the
underlying links between the heart, kidneys and pancreas. DAPA-HF
is part of DapaCare, a robust clinical trial programme to assess
the potential CV and renal benefits of Forxiga. The programme has also explored the treatment of
patients with chronic kidney disease (CKD) in the ground-breaking
DAPA-CKD Phase III trial. Additionally, Forxiga is currently being tested for HF patients
with preserved ejection fraction (HFpEF) in the DELIVER Phase III
trial with data anticipated in the second half of
2021.
Heart failure
HF affects approximately 64 million people worldwide (at least half
of whom have a reduced ejection fraction), including 15 million in
the EU and six million in the US.2-3,8 It
is a chronic disease where half of patients will die within five
years of diagnosis.9 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 HFpEF.7 HFrEF
occurs when the left ventricle muscle is not able to contract
adequately and therefore, expels less oxygen-rich blood in to the
body.5,6 HF
remains as fatal as some of the most common cancers in both men
(prostate and bladder cancers) and women (breast
cancer).10 It
is the leading cause of hospitalisation for those over the age of
65 and represents a significant clinical and economic
burden.11
DAPA-HF
DAPA-HF (Dapagliflozin And Prevention of Adverse-outcomes in Heart
Failure) is an international, multi-centre, parallel-group,
randomised, double-blinded Phase III trial in 4,744 patients with
heart failure and reduced ejection fraction (LVEF ≤ 40%),
with and without T2D, designed to evaluate the effect
of Forxiga 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.
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.
Mayo Clinic. Heart failure; 29 May 2020 [cited 21 October 2020].
Available from: URL:
https://www.mayoclinic.org/diseases-conditions/heart-failure/symptoms-causes/syc-20373142.
2. Dickstein K, et al. ESC
Guidelines for the diagnosis and treatment of acute and chronic
heart failure 2008: the Task Force for the Diagnosis and Treatment
of Acute and Chronic Heart Failure 2008 of the European Society of
Cardiology. Developed in collaboration with the Heart Failure
Association of the ESC (HFA) and endorsed by the European Society
of Intensive Care Medicine (ESICM). Eur Heart J 2008; 29:2388-2442.
3. Travessa AMR, Menezes Falcão
LF de. Treatment of Heart Failure With Reduced Ejection
Fraction-Recent Developments. Am J Ther
2016;
23(2):e531-49.
4. American Heart
Association. Ejection Fraction Heart Failure Measurement; 2017
[cited 2 Nov 2020]. Available from: URL: https://www.heart.org/en/health-topics/heart-failure/diagnosing-heart-failure/ejection-fraction-heart-failure-measurement.
5. 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.).
6.
National Guideline Centre (UK). Chronic Heart Failure in Adults:
Diagnosis and Management. London: National Institute for Health and
Care Excellence (UK); 2018 Sep. (NICE Guideline, No. 106.) 13,
Glossary.
7. McMurray JJV et al. Dapagliflozin
in Patients with Heart Failure and Reduced Ejection
Fraction. N Engl J
Med 2019.
8. 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.
9. Mozaffarian D et al. Heart Disease
and Stroke Statistics-2016 Update: A Report From the American Heart
Association. Circulation 2016; 133(4):e38-360.
10. 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.
11. Azad N, Lemay G. Management of chronic
heart failure in the older population. J Geriatr
Cardiol 2014;
11(4):329-37.
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:
05 November
2020
|
By: /s/
Adrian Kemp
|
|
Name:
Adrian Kemp
|
|
Title:
Company Secretary
|
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