TIDMAZN
RNS Number : 8102Y
AstraZeneca PLC
06 January 2020
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.
Media Relations
Gonzalo Viña +44 203 749 5916
Rob Skelding Oncology +44 203 749 5821
Rebecca Einhorn Oncology +1 301 518 4122
Matt Kent BioPharmaceuticals +44 203 749 5906
Angela Fiorin BioPharmaceuticals +44 1223 344 690
Jennifer Hursit Other +44 203 749 5762
Christina Malmberg Hägerstrand Sweden +46 8 552 53 106
Michele Meixell US +1 302 885 2677
Investor Relations
Thomas Kudsk Larsen +44 203 749 5712
Henry Wheeler Oncology +44 203 749 5797
Christer Gruvris BioPharmaceuticals (Cardiovascular, Metabolism) +44 203 749 5711
BioPharmaceuticals (Renal) Environmental, Social and
Nick Stone Governance +44 203 749 5716
BioPharmaceuticals (Respiratory)
Josie Afolabi Other medicines +44 203 749 5631
Finance
Craig Marks Fixed income +44 7881 615 764
Corporate access
Jennifer Kretzmann Retail investors +44 203 749 5824
US toll-free +1 866 381 72 77
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
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
END
MSCFIFLRLAIRIII
(END) Dow Jones Newswires
January 06, 2020 02:01 ET (07:01 GMT)
Astrazeneca (LSE:AZN)
Historical Stock Chart
From Apr 2024 to May 2024
Astrazeneca (LSE:AZN)
Historical Stock Chart
From May 2023 to May 2024