a8902g
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
CB2 0AA
United
Kingdom
Indicate
by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
Form
20-F X Form 40-F __
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(1):
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(7): ______
Indicate
by check mark whether the registrant by furnishing the information
contained in this Form is also thereby furnishing the information
to the Commission pursuant to Rule 12g3-2(b) under the Securities
Exchange Act of 1934.
Yes __
No X
If
“Yes” is marked, indicate below the file number
assigned to the Registrant in connection with Rule 12g3-2(b):
82-_____________
AstraZeneca PLC
INDEX
TO EXHIBITS
1.
Forxiga approved in Japan
for chronic heart failure
30 November 2020 07:00 GMT
Forxiga approved in Japan for chronic heart
failure
Forxiga is the first SGLT2 inhibitor approved in Japan for chronic
heart failure
with reduced ejection fraction in adult patients with and without
type-2 diabetes
AstraZeneca's Forxiga (dapagliflozin) has been approved in Japan
for the treatment of patients with chronic heart failure (HF) who
are receiving standard of care.
HF is a life-threatening chronic disease that prevents the heart
from pumping sufficient levels of blood around the body. It affects
approximately 64 million people worldwide, at least half of whom
have a reduced ejection fraction.1-3 This
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 Japanese Ministry of Health, Labour and Welfare
(MHLW) was based on positive results from the landmark DAPA-HF
Phase III trial published in The
New England Journal of Medicine.7
Masafumi Kitakaze, Director of Hanwa Daini Senboku Hospital, Guest
Professor of the Graduate School of Medicine, University of Osaka
and Investigator of the DAPA-HF Phase III trial in Japan, said:
"Heart failure is a condition affecting 1.3 million people in
Japan. Many patients have considerably reduced heart function, such
as left ventricular reduced ejection fraction. Approximately half
of patients will die within five years of diagnosis, which is worse
than some cancers. With no known cure except for heart transplant,
a new effective treatment option on top of the current standard of
care may offer hope for people struggling with this disease and a
new tool for cardiologists."
Mene Pangalos, Executive Vice President, BioPharmaceuticals
R&D, said: "Forxiga's efficacy in reducing the risk of cardiovascular
death or worsening of heart failure events could result in
life-saving benefits for many heart failure patients in Japan.
Today's approval will shift the way we manage the disease by
providing a treatment option that is urgently needed to improve
outcomes and symptoms for these patients."
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 resulting in intravenous therapy associated
with HF could be avoided for every 21 patients
treated.
Forxiga (known
as Farxiga in the US) is approved in
the US, Europe,
and several other countries around the world for the treatment of
patients with HF with reduced ejection fraction
(HFrEF).
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 readout
anticipated in the second half of 2021.
In 2013, AstraZeneca K.K. (AZKK), a subsidiary in Japan of
AstraZeneca, entered into an agreement with Ono Pharmaceutical
for Forxiga. Based on this agreement, Ono is responsible for
distribution and marketing of Forxiga tablets in Japan and has been co-promoting
it with AZKK for the treatment of T2D and type-1 diabetes. Both
companies will co-promote for the treatment of chronic heart
failure.
Heart failure
HF affects approximately 64 million people worldwide (at least half
of whom have a reduced ejection fraction), including 1.3 million in
Japan, 15 million in the EU and six million in the
US.2-3,8,9 It
is a chronic disease where half of patients will die within five
years of diagnosis.10 HFrEF
and HFpEF are the two main categories of HF related to ejection
fraction, a measurement of the percentage of blood leaving the
heart each time it contracts.7 HFrEF
occurs when the left ventricle muscle is not able to contract
adequately and therefore, expels less oxygen-rich blood into 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).11 It
is the leading cause of hospitalisation for those over the age of
65 and represents a significant clinical and economic
burden.12
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 HFrEF (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 CV 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 CV 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. 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.
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. AstraZeneca. Data on
File. November 2020.
9. 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.
10. Mozaffarian D et
al. Circulation. 26 January 2016;133(4):e38-360
and the CDC:
https://www.cdc.gov/dhdsp/data_statistics/fact_sheets/fs_heart_failure.htm.
11. 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.
12. 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:
30 November
2020
|
By: /s/
Adrian Kemp
|
|
Name:
Adrian Kemp
|
|
Title:
Company Secretary
|