Blueprint
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 January
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 granted FDA Priority Review
for patients with heart failure with reduced
ejection fraction
6 January 2020 07:01 GMT
Farxiga granted FDA Priority Review for
patients
with heart failure with reduced ejection fraction
AstraZeneca today announced the US Food and Drug Administration
(FDA) has accepted a supplemental New Drug Application (sNDA) and
granted Priority Review for Farxiga (dapagliflozin) to reduce the risk of
cardiovascular (CV) death or the worsening of heart failure (HF) in
adults with heart failure with reduced ejection fraction
(HFrEF) with and without type-2 diabetes
(T2D). Farxiga is
a first-in-class, oral once-daily selective inhibitor of human
sodium-glucose co-transporter 2 (SGLT2).
The Prescription Drug User Fee Act date, the FDA action date for
this supplemental application, is scheduled for the second quarter
of 2020.
The sNDA was based on results from the landmark Phase III
DAPA-HF trial published in September 2019
in The
New England Journal of Medicine, which showed Farxiga on top of standard of care reduced the
incidence of the composite outcome of CV death or the worsening of
HF versus placebo.
Mene Pangalos, Executive Vice President, BioPharmaceuticals
R&D, said: "Farxiga is well established in the treatment of
type-2 diabetes and this Priority Review shows its potential to
also impact millions of patients with heart failure. If
approved, Farxiga will be the first and only medicine of its
kind indicated to treat patients with heart
failure."
In September 2019, the FDA
granted Fast Track designation for the development
of Farxiga in HF. In August
2019, the FDA also granted Fast
Track designation for the development of Farxiga to delay the progression of renal failure
and prevent CV and renal death in patients with chronic kidney
disease, with and without T2D.
Farxiga is indicated as a
monotherapy and as part of combination therapies to improve
glycaemic control in adults with T2D. In October
2019, the FDA also
approved Farxiga to reduce the risk of hospitalisation for
heart failure in patients with T2D and established cardiovascular
disease or multiple CV risk factors.
Heart failure
Heart failure (HF) is a life-threatening disease in which the heart
cannot pump enough blood around the body.1 It
affects approximately 64 million people worldwide (at least half of
which have a reduced ejection fraction) and is a chronic and
degenerative disease where half of patients will die within five
years of diagnosis.2,3,4 HF
remains as fatal as some of the most common cancers in both men
(prostate and bladder cancers) and women (breast
cancers).5 It
is the leading cause of hospitalisation for those over the age of
65 and represents a significant clinical and economic
burden.6
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 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.
Farxiga
Farxiga (dapagliflozin) is
a first-in-class, oral once-daily SGLT2 inhibitor indicated as both
monotherapy and as part of combination therapies 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.
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.
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.
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References
1. Mayo
Clinic. Heart failure; 2017 [cited 2019 Aug 14]. 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.
doi:10.1097/MJT.0000000000000406.
4. 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
5. Mamas,
M. A., Sperrin, M., Watson, M. C., Coutts, A., Wilde, K., Burton,
C., ... Myint, P. K. (2017). Do patients have worse outcomes in
heart failure than in cancer? A primary care-based cohort study
with 10-year follow-up in Scotland. European
Journal of Heart Failure, 19(9),
1095-1104. https://doi.org/10.1002/ejhf.822
6. Azad, N., & Lemay, G. (2014). Management of
chronic heart failure in the older
population. Journal of Geriatric
Cardiology: JGC, 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:
06 January
2020
|
By: /s/
Adrian Kemp
|
|
Name:
Adrian Kemp
|
|
Title:
Company Secretary
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