REG - AstraZeneca PLC - Farxiga extended in the US for heart failure

AstraZenecaAnnouncement

09/05/2023 07:15

For best results when printing this announcement, please click on link below:
http://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20230509:nRSI7677Ya&default-theme=true

RNS Number : 7677Y  AstraZeneca PLC  09 May 2023

9 May 2023

 

Farxiga extended in the US to reduce risk of cardiovascular death and
hospitalisation for heart failure to a broader range of patients

 

FDA approval means patients with heart failure can benefit from Farxiga

regardless of left ventricular ejection fraction status

 

AstraZeneca's Farxiga (dapagliflozin) has been approved in the US to reduce
the risk of cardiovascular (CV) death, hospitalisation for heart failure (hHF)
and urgent heart failure (HF) visits in adults with HF. The approval by the
Food and Drug Administration (FDA) was based on positive results from the
DELIVER Phase III trial.(1) Farxiga was previously approved in the US for
adults with HF with reduced ejection fraction (HFrEF).

 

Ruud Dobber, Executive Vice-President, BioPharmaceuticals Business Unit,
AstraZeneca, said: "Approximately half of heart failure patients die within
five years of diagnosis, highlighting an urgent unmet need for well-tolerated
treatment options that can bring life-saving benefits and reduce the risk of
cardiovascular death. The approval of Farxiga in the US not only reinforces
AstraZeneca's commitment to reducing the burden of this complex and
life-threatening disease, but will help patients across the full spectrum of
heart failure lead healthier lives."

 

HF is a chronic, long-term condition that worsens over time(2) and affects
almost seven million people in the US.(3) It is also the leading cause of
hospitalisation for those over 65 years and represents a significant clinical
and economic burden.(4) Approximately half of all HF patients have HF with
mildly reduced ejection fraction (HFmrEF) or HF with preserved ejection
fraction (HFpEF)(5) and these patients are not only at greater risk of death
and hospitalisations but experience an especially high burden of symptoms and
physical limitations, and a poor quality of life.(6)

 

The data from the DELIVER Phase III trial, published in The New England
Journal of Medicine (https://www.nejm.org/doi/full/10.1056/NEJMoa2206286) ,
showed Farxiga reached a statistically significant and clinically meaningful
early reduction in the primary composite endpoint of CV death or worsening HF
in patients with HF with HFmrEF or HFpE.F(1) The results from a pre-specified,
pooled analysis of the DAPA-HF and DELIVER Phase III trials, published in
Nature Medicine (https://www.nature.com/articles/s41591-022-01971-4) , showed
that the treatment effect of Farxiga on the composite endpoint of
cardiovascular death, hospitalisation for heart failure or urgent heart
failure was consistent across the left ventricular ejection fraction (LVEF)
 range and established Farxiga as the first sodium-glucose cotransporter 2
(SGLT2) inhibitor to demonstrate a mortality benefit.(7)

 

Farxiga is approved for the treatment of patients with type-2 diabetes (T2D),
HFrEF and chronic kidney disease (CKD) in more than 100 countries around the
world including the US, the European Union (EU), China and Japan. It has most
recently received regulatory approvals in the EU, Great Britain, Japan and
Turkey to extend the HF indication to include patients across the full LVEF
range.

Notes

HF
HF is a chronic, long-term condition that worsens over time.(2) It affects
nearly 64 million people globally(8) and is associated with substantial
morbidity and mortality.(9) Chronic HF is the leading cause of hospitalisation
for those over the age of 65 and represents a significant clinical and
economic burden.(4) There are several types of HF often defined by LVEF, a
measurement of the percentage of blood leaving the heart each time it
contracts, including: HFrEF (LVEF less than or equal to 40%), HFmrEF (LVEF
41-49%) and HFpEF (LVEF greater than or equal to 50%).(10) Approximately half
of all HF patients have HFmrEF or HFpEF,(5) with few therapeutic options
available.(6)

DELIVER
DELIVER was an international, randomised, double-blind, parallel-group,
placebo-controlled, event-driven Phase III trial designed to evaluate the
efficacy of Farxiga, compared with placebo, in the treatment of HF patients
with LVEF greater than 40%, with or without T2D. Farxiga was given once
daily in addition to background therapy (regional SoC for all comorbidities,
including diabetes and hypertension, with the exception of concomitant use of
a sodium-glucose cotransporter 2 (SGLT2) inhibitor).( )DELIVER is the largest
clinical trial to date in HF patients with LVEF above 40%, with 6,263
randomised patients.(11)

The primary composite endpoint was the time to first occurrence of CV death,
hHF or an urgent HF visit. Key secondary endpoints include the total number of
HF events (hHF or urgent HF visit) and CV death, change from baseline in the
total symptom score of the KCCQ at eight months, time to the occurrence of CV
death and time to the occurrence of death from any cause.(11)

Farxiga
Farxiga (dapagliflozin) is a first-in-class, oral, once-daily SGLT2
inhibitor. Research has shown Farxiga's efficacy in preventing and delaying
cardiorenal disease, while also protecting the organs - important findings
given the underlying links between the heart, kidneys and( )pancreas.(12-14)
Damage to one of these organs can cause the other organs to fail, contributing
to leading causes of death worldwide, including T2D, HF and CKD.(15-17)

AstraZeneca in CVRM

Cardiovascular, Renal and Metabolism (CVRM), part of BioPharmaceuticals, forms
one of AstraZeneca's main disease 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 for organ protection and improving outcomes by slowing
disease progression, reducing risks and tackling co-morbidities. 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 in Oncology, Rare Diseases, and BioPharmaceuticals,
including 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
(https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.astrazeneca.com%2F&data=05%7C01%7Celizabeth.hathaway%40edelman.com%7C690c690f1800412f9ae808db1f4a3b20%7Cb824bfb3918e43c2bb1cdcc1ba40a82b%7C0%7C0%7C638138175902946200%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=t2GNZ2BVX8wP70PFZSDEie363CTDSaa2SZiqd1O4KPk%3D&reserved=0)
and follow the Company on Twitter @AstraZeneca
(https://twitter.com/AstraZeneca) .

 

References

1.   Solomon S, et al. Dapagliflozin in heart failure with mildly reduced or
preserved ejection fraction. N Engl J Med. 2022; 387(12):1089-1098.

2.   Cleveland Clinic  Internet . Heart failure [cited 2023 Mar 14].
Available
from: https://my.clevelandclinic.org/health/diseases/17069-heart-failure-understanding-heart-failure
(https://my.clevelandclinic.org/health/diseases/17069-heart-failure-understanding-heart-failure)
.

3.   Tsao C., et al. Heart Disease and Stroke Statistics-2022 Update: A
Report From the American Heart Association. Circulation. 2023;144(8):e7,
e431-444.

4.   Azad N, et al. Management of chronic heart failure in the older
population. J Geriatr Cardiol. 2014;11(4):329-337.

5.   McDonagh T, et al. 2021 ESC Guidelines for the diagnosis and treatment
of acute and chronic heart failure. Eur Heart J. 2021;00:1-128.

6.   Kosiborod MN, et al. The effects of dapagliflozin on symptoms, function
and quality of life in patients with heart failure and mildly reduced or
preserved ejection fraction: results from the DELIVER Trial. Presented at:
American Heart Association (AHA) Scientific Sessions 2022, 5-7 November 2022,
Chicago, Illinois, USA.

7.   Jhund P, et al. Dapagliflozin across the range of ejection fraction in
patients with heart failure: a patient-level, pooled meta-analysis of DAPA-HF
and DELIVER. Nat Med. 2022; 28(9):1956-1964.

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. Lancet. 2017;390(10100):1211-1259.

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.  Heidenreich PA et al. 2022 AHA/ACC/HFSA Guideline for the Management of
Heart Failure: A report of the American College of Cardiology/American Heart
Association Joint Committee on Clinical Practice Guidelines. J Am Coll
Cardiol. 2022;79(17):e263-421.

11.  Solomon SD, et al. Dapagliflozin in heart failure with preserved and
mildly reduced ejection fraction: rationale and design of the DELIVER
trial. Eur J Heart Fail. 2021;23(7):1217-1225

12.  McMurray JJV, et al. Dapagliflozin in patients with heart failure and
reduced ejection fraction. N Engl J Med. 2019;381(21):1995-2008.

13.  Heerspink HJL, et al. Dapagliflozin in patients with chronic kidney
disease. N Engl J Med. 2020;383(15):1436-1446.

14.  Wiviott SD, et al; for the DECLARE-TIMI 58 Investigators. Dapagliflozin
and cardiovascular outcomes in type 2 diabetes [article and supplementary
appendix]. N Engl J Med. 2019;380(4):347-357.

15.  Mayo Clinic  Internet . Heart failure [cited 2023 Mar 14]. Available
from: https://www.mayoclinic.org/diseases-conditions/heart-failure/symptoms-causes/syc-20373142
(https://www.mayoclinic.org/diseases-conditions/heart-failure/symptoms-causes/syc-20373142)
.

16.  Centers for Disease Control and Prevention (CDC)  Internet . A snapshot:
Diabetes in the United States [cited 2023 Mar 14]. Available
from: https://www.cdc.gov/diabetes/library/socialmedia/infographics/diabetes.html
(https://www.cdc.gov/diabetes/library/socialmedia/infographics/diabetes.html)
.

17.  National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
 Internet . Heart disease & kidney disease [cited 2023 Mar 14]. Available
from: https://www.niddk.nih.gov/health-information/kidney-disease/heart-disease
(https://www.niddk.nih.gov/health-information/kidney-disease/heart-disease) .

 

 

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 (mailto:rns@lseg.com)
 or visit
www.rns.com (http://www.rns.com/)
.

RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
.   END  MSCEASSNESXDEEA