TIDMAZN
RNS Number : 0846M
AstraZeneca PLC
06 May 2020
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
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END
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