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2025-02-06 - Bokslutskommuniké 2024
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2024-08-08 - X-dag halvårsutdelning AZN 77.600002
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2024-04-25 - Kvartalsrapport 2024-Q1
2024-04-11 - Årsstämma
2024-02-22 - X-dag halvårsutdelning AZN 155.999994
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2023-11-09 - Kvartalsrapport 2023-Q3
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2023-04-27 - Årsstämma
2023-04-27 - Kvartalsrapport 2023-Q1
2023-02-23 - X-dag halvårsutdelning AZN 162.800002
2023-02-09 - Bokslutskommuniké 2022
2022-11-10 - Kvartalsrapport 2022-Q3
2022-08-11 - X-dag halvårsutdelning AZN 76.4
2022-07-29 - Kvartalsrapport 2022-Q2
2022-04-29 - Årsstämma
2022-04-29 - Kvartalsrapport 2022-Q1
2022-02-24 - X-dag halvårsutdelning AZN 145.299995
2022-02-10 - Bokslutskommuniké 2021
2021-11-12 - Kvartalsrapport 2021-Q3
2021-08-12 - X-dag halvårsutdelning AZN 64.8
2021-07-29 - Kvartalsrapport 2021-Q2
2021-05-11 - Årsstämma
2021-04-30 - Kvartalsrapport 2021-Q1
2021-02-25 - X-dag halvårsutdelning AZN 137.399995
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2020-11-05 - Kvartalsrapport 2020-Q3
2020-08-13 - X-dag halvårsutdelning AZN 69.599998
2020-07-30 - Kvartalsrapport 2020-Q2
2020-04-29 - Årsstämma
2020-04-29 - Kvartalsrapport 2020-Q1
2020-02-27 - X-dag halvårsutdelning AZN 146.399999
2020-02-14 - Bokslutskommuniké 2019
2019-10-24 - Kvartalsrapport 2019-Q3
2019-08-08 - X-dag halvårsutdelning AZN 71.899998
2019-07-25 - Kvartalsrapport 2019-Q2
2019-04-26 - Årsstämma
2019-04-26 - Kvartalsrapport 2019-Q1
2019-02-28 - X-dag halvårsutdelning AZN 146.800005
2019-02-14 - Bokslutskommuniké 2018
2018-11-08 - Kvartalsrapport 2018-Q3
2018-08-09 - X-dag halvårsutdelning AZN 68.400002
2018-07-26 - Kvartalsrapport 2018-Q2
2018-05-18 - Årsstämma
2018-05-18 - Kvartalsrapport 2018-Q1
2018-02-15 - X-dag halvårsutdelning AZN 133.599997
2018-02-02 - Bokslutskommuniké 2017
2017-11-09 - Kvartalsrapport 2017-Q3
2017-08-10 - X-dag halvårsutdelning AZN 68.900001
2017-07-27 - Kvartalsrapport 2017-Q2
2017-04-27 - Årsstämma
2017-04-27 - Kvartalsrapport 2017-Q1
2017-02-16 - X-dag halvårsutdelning AZN 150.199997
2017-02-02 - Bokslutskommuniké 2016
2016-11-10 - Kvartalsrapport 2016-Q3
2016-08-11 - X-dag halvårsutdelning AZN 68.699998
2016-07-28 - Kvartalsrapport 2016-Q2
2016-04-29 - Årsstämma
2016-04-29 - Kvartalsrapport 2016-Q1
2016-02-18 - X-dag halvårsutdelning AZN 145.555556
2016-02-04 - Bokslutskommuniké 2015
2015-11-05 - Kvartalsrapport 2015-Q3
2015-08-13 - X-dag halvårsutdelning AZN 63.88889
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2015-04-24 - Årsstämma
2015-04-24 - Kvartalsrapport 2015-Q1
2015-02-19 - X-dag halvårsutdelning AZN 138.888896
2015-02-05 - Bokslutskommuniké 2014
2014-11-06 - Kvartalsrapport 2014-Q3
2014-08-13 - X-dag halvårsutdelning AZN 59
2014-07-31 - Kvartalsrapport 2014-Q2
2014-04-24 - Årsstämma
2014-04-24 - Kvartalsrapport 2014-Q1
2014-02-19 - X-dag halvårsutdelning AZN 129.777777
2014-02-06 - Bokslutskommuniké 2013
2013-10-31 - Kvartalsrapport 2013-Q3
2013-08-14 - X-dag halvårsutdelning AZN 65.777779
2013-08-01 - Analytiker möte 2013
2013-08-01 - Kvartalsrapport 2013-Q2
2013-04-25 - Årsstämma
2013-04-25 - Kvartalsrapport 2013-Q1
2013-02-13 - X-dag halvårsutdelning AZN 133.888888
2013-01-31 - Bokslutskommuniké 2012
2012-10-25 - Analytiker möte 2012
2012-10-25 - Kvartalsrapport 2012-Q3
2012-08-08 - X-dag halvårsutdelning AZN 64.555556
2012-07-26 - Kvartalsrapport 2012-Q2
2012-04-26 - Årsstämma
2012-04-26 - Kvartalsrapport 2012-Q1
2012-02-15 - X-dag halvårsutdelning AZN 137.333333
2012-02-02 - Bokslutskommuniké 2011
2011-10-27 - Kvartalsrapport 2011-Q3
2011-08-03 - X-dag halvårsutdelning AZN 57.666665
2011-07-28 - Kvartalsrapport 2011-Q2
2011-04-28 - Årsstämma
2011-04-28 - Kvartalsrapport 2011-Q1
2011-02-02 - X-dag halvårsutdelning AZN 129.666662
2011-01-27 - Bokslutskommuniké 2010
2010-10-28 - Kvartalsrapport 2010-Q3
2010-08-04 - X-dag halvårsutdelning AZN 49.888888
2010-07-29 - Kvartalsrapport 2010-Q2
2010-04-29 - Kvartalsrapport 2010-Q1
2010-02-03 - X-dag halvårsutdelning AZN 117.111111
2010-01-28 - Bokslutskommuniké 2009
2009-10-29 - Kvartalsrapport 2009-Q3
2009-08-05 - X-dag halvårsutdelning AZN 40
2009-07-30 - Kvartalsrapport 2009-Q2
2009-04-30 - Årsstämma
2009-04-30 - Kvartalsrapport 2009-Q1
2009-02-04 - X-dag halvårsutdelning AZN 116.444444
2008-08-06 - X-dag halvårsutdelning AZN 30.888888
2008-02-06 - X-dag halvårsutdelning AZN 75.2222222
2007-08-08 - X-dag halvårsutdelning AZN 28.111111
2007-02-07 - X-dag halvårsutdelning AZN 70
2006-08-09 - X-dag halvårsutdelning AZN 32.562658

Beskrivning

LandStorbritannien
ListaFTSE 100
SektorHälsovård
IndustriLäkemedel & Handel
AstraZeneca är ett globalt läkemedelsbolag med fokus på forskning, utveckling och marknadsföring av receptbelagda läkemedel, primärt för behandling av sjukdomar inom terapiområdena som berör andningsvägar, hjärta/kärl/metabolism och cancer. Utöver huvudverksamheten är bolaget även aktiva inom autoimmunitet, neurovetenskap och infektion. AstraZeneca är verksamt inom samtliga globala regioner och har sitt huvudkontor i Cambridge, Storbritannien.
2023-08-18 08:02:23

The first and only heart failure therapy with a proven mortality benefit now approved for patients with heart failure regardless of ejection fraction status.

Forxiga (dapagliflozin) has been approved in China to reduce the risk of cardiovascular death, hospitalisation for heart failure (HF), or urgent HF visits in adults with symptomatic chronic HF. Forxiga has previously been approved in China for HF patients with reduced ejection fraction (HFrEF) meaning that Forxiga is now approved in China to reduce the risk of cardiovascular death and hospitalisations in adult patients with symptomatic chronic HF regardless of ejection fraction phenotype.

The approval by China's National Medical Products Administration (NMPA) is based on positive results from the DELIVER Phase III trial. Results from the prespecified pooled analysis of DELIVER and DAPA-HF Phase III trials also established dapagliflozin as the first HF medication to demonstrate a mortality benefit across the full ejection fraction range.[1,2]

Ruud Dobber, Executive Vice President, and President BioPharmaceuticals Business Unit, AstraZeneca, said: "This broader indication for Forxiga in adults with symptomatic chronic heart failure across the full ejection fraction range is a significant advancement for patients. It represents an exciting turning point in the battle against heart failure given the unmet treatment needs and the absence until now of treatments that reduce mortality in this setting. Importantly, this development underscores our commitment to accelerating earlier detection and coordinated care, to address the complexities of heart failure across the disease spectrum."

HF is a complex syndrome that occurs when the heart cannot pump enough blood around the body.[3] HF affects approximately 4.5 million people in China.[4] Around half of HF patients die within five years of diagnosis.[5] Patients with ejection fraction above 40% are at greater risk of death and hospitalisation and experience an especially high burden of symptoms and physical limitations, and consequently have a poor quality of life.[6] The economic burden of HF in China is huge in terms of healthcare costs and resource utilisation, and hospitalisation is the major contributor to the HF treatment burden - the mean hospital stay for HF patients is 30 days in one year.[7]

Forxiga is also approved for the treatment of patients with T2D, HFrEF and CKD in more than 100 countries around the world including China, Japan, the US, and the EU.

Notes

Heart Failure
Heart Failure (HF) is a chronic, long-term condition that worsens over time.[8] It affects nearly 64 million people globally[9] and is associated with substantial morbidity and mortality.[10] Chronic HF is the leading cause of hospitalisation for those over the age of 65 and represents a significant clinical and economic burden.[11] There are several types of HF often defined by left ventricular ejection fraction (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%).[12 ]Approximately half of all HF patients have HFmrEF or HFpEF, with few therapeutic options available.[13]

DELIVER 
DELIVER (Dapagliflozin Evaluation to Improve the LIVEs of Patients with Preserved Ejection Fraction Heart Failure) was an international, randomised, double-blind, parallel-group, placebo-controlled, event-driven Phase III trial designed to evaluate the efficacy of Forxiga, compared with placebo, in the treatment of HF patients with LVEF above 40%, with or without type 2 diabetes (T2D). DELIVER is the largest clinical trial to date in HF patients with LVEF above 40%, with 6,263 randomised patients.[14] Results from the DELIVER Phase III trial showed that Forxiga met its primary endpoint in reducing the composite outcome of cardiovascular (CV) death or worsening HF by 18% (16.4% in the Forxiga group and 19.5% in the placebo group over a median follow-up of 2.3 years [hazard ratio {HR} =0.82 {95% CI 0.73-0.92}; p<0.001, ARR 3.1%]).[14]

DAPA-HF 
DAPA-HF (Dapagliflozin And Prevention of Adverse-outcomes in Heart Failure) was an international, multi-centre, parallel-group, randomised, double-blinded Phase III trial in 4,744 patients with HFrEF, 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 HF event (hospitalisation or equivalent event, i.e., an urgent HF visit), or cardiovascular (CV) death. The median duration of follow-up was 18.2 months.[15] Key secondary endpoints included the total number of hospitalisations for HF (hHF) (including repeat admissions) and CV deaths, change from baseline to 8 months in the total symptom score on the Kansas City Cardiomyopathy Questionnaire (KCCQ).[15]

Forxiga (dapagliflozin)
Forxiga is a first-in-class, oral, once-daily selective inhibitor of human sodium-glucose co-transporter 2 (SGLT2). Forxiga is indicated to reduce the risk of cardiovascular death, hospitalisation for HF, or urgent HF visits in adults with symptomatic chronic heart failure.[16] Forxiga is also approved in China for adults with chronic kidney disease (CKD) and for the treatment of insufficiently controlled type 2 diabetes (T2D) as an adjunct to diet and exercise.  Research has shown  Forxiga'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.[15, 17-18] 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.[3, 9, 19-20]

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, liver and pancreas, AstraZeneca is investing in a portfolio of medicines for organ protection by slowing or stopping disease progression, and ultimately paving the way towards regenerative therapies. The Company's ambition is to improve and save the lives of millions of people, by better understanding the interconnections between CVRM diseases and targeting the mechanisms that drive them, so we can detect, diagnose and treat people earlier and more effectively.

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 (http://www.astrazeneca.com/) and follow the Company on social media @AstraZeneca (https://gateway.zscalertwo.net/auD?origurl=https:%2f%2fwww.linkedin.com%2fcompany%2fastrazeneca&_ordtok=Mkk3WV5DBDPmQrD4F5MGdGDMZR)

Contacts
For details on how to contact the Investor Relations Team, please click here (https://www.astrazeneca.com/investor-relations.html#Contacts). For Media contacts, click here (https://www.astrazeneca.com/media-centre/contacts.html).
 

References

1. Jhund PS, 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):1956-64.
2. Solomon S, et al. Dapagliflozin in heart failure with mildly reduced or preserved ejection fraction. N Engl J Med. 2022; 387(12):1089-1098.
3. Mayo Clinic [Internet]. Heart failure; [cited 2023 Aug 1]. Available from: https://www.mayoclinic.org/diseases-conditions/heart-failure/symptoms-causes/syc-20373142.  
4. Guo Y, et al. Heart Failure in East Asia. Current Cardiology Reviews. 2013;9:112-122.
5. Tsao CW, et al. Heart Disease and Stroke Statistics-2023 Update. Circulation. 2023;147:e93-e621. PMID: 36695182.
6. Warraich HJ, et al. Physical function, frailty, cognition, depression, and quality of life in hospitalized adults ≥60 years with acute decompensated heart failure with preserved versus reduced ejection fraction. Circ Heart Fail. 2018;11(11):e005254.
7. Oberfrank F, et al. Economic Burden of Heart Failure in Chinese Population. Value In Health. 2016;19:A347 - A766.
8. Cleveland Clinic [Internet]. Heart failure; [cited 2023 Aug 1]. Available from: https://my.clevelandclinic.org/health/diseases/17069-heart-failure-understanding-heart-failure.
9. 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.
10. Mozaffarian D, et al. Heart Disease and Stroke Statistics-2016 Update: A Report From the American Heart Association. Circulation. 2016;133(4):e38-360.
11. 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.
12. 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.  Journal of American College of Cardiology. 2008;10(10):933-989.
13. 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.
14. 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.
15. McMurray JJV, et al. Dapagliflozin in patients with heart failure and reduced ejection fraction. N Engl J Med. 2019;381(21):1995-2008.
16. Forxiga Prescribing Information.
17. Heerspink HJL, et al. Dapagliflozin in patients with chronic kidney disease. N Engl J Med. 2020;383(15):1436-1446. 
18. 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.
19. Centers for Disease Control and Prevention (CDC) [Internet]. A snapshot: Diabetes in the United States; [cited 2023 Aug 1]. Available from: https://www.cdc.gov/diabetes/library/socialmedia/infographics/diabetes.html.
20. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) [Internet]. Heart disease & kidney disease; [cited 2023 Aug 1]. Available from: https://www.niddk.nih.gov/health-information/kidney-disease/heart-disease.