MORE PATIENTS ACROSS ENGLAND AND WALES ARE SET TO BECOME ELIGIBLE FOR ASTRAZENECA’S FORXIGA (DAPAGLIFLOZIN) FOR THE TREATMENT OF CHRONIC KIDNEY DISEASE

MORE PATIENTS ACROSS ENGLAND AND WALES ARE SET TO BECOME ELIGIBLE FOR ASTRAZENECA’S FORXIGA (DAPAGLIFLOZIN) FOR THE TREATMENT OF CHRONIC KIDNEY DISEASE

• Following the review of additional clinical data, the National Institute for Health and Care Excellence (NICE) has published updated Final Draft Guidance recommending dapagliflozin as a treatment option for Chronic Kidney Disease (CKD), for an expanded patient population.[i]
• The decision from NICE was informed by Real-World Evidence (RWE) demonstrating the use of dapagliflozin for the treatment of CKD and clinical trial data from previous studies of dapagliflozin.¹
• There are currently more than 7 million people living with CKD in the UK, equating to more than 10% of the entire population.[ii] Around 1 million of these are unaware they have this condition which causes up to 45,000 premature deaths every year in the UK.[iii]^,[iv]

London, UK, Friday 30 May 2025 – Today, AstraZeneca announced that the National Institute for Health and Care Excellence (NICE) has published updated Final Draft Guidance recommending Forxiga (dapagliflozin) as an option to treat chronic kidney disease in adults, if:¹

• It is an add-on to optimised standard care including the highest tolerated licensed dose of angiotensin-converting enzyme (ACE) inhibitors and angiotensin-2 receptor antagonists, unless these are contraindicated, and
• People have an estimated glomerular filtration rate (eGFR) of:
  • 20 ml/min/1.73 m² to less than 45 ml/min/1.73 m² or
  • 45 ml/min/1.73 m² to 90 ml/min/1.73 m², and either:
    • A urine albumin-to-creatine ratio (uACR) of 22.6 mg/mmol or more, or
    • Type 2 diabetes

This evaluation was a review of NICE’s technology appraisal guidance on dapagliflozin for treating CKD, published in 2022.^1,[v] It also reviewed new data submitted by AstraZeneca as part of this evaluation.¹

Today’s decision from NICE means dapagliflozin is now recommended as a treatment option for CKD in a wider patient population – expanding patient access outside of the eGFR restrictions outlined in NICE’s final appraisal document in 2022.^1,5  

NICE's decision comes soon after the acceptance from the Scottish Medicines Consortium (SMC) for the same indication and expanded patient population in April 2025.

CKD is a long-term condition, categorised by the gradual loss of kidney function – hindering the removal of waste products from the body.[vi]^,[vii] An estimated 7.2 million people in the UK currently live with CKD, which equates to more than 10% of the entire population.² Of these, around 1 million are unaware they have this condition.³

With cases in the UK growing so rapidly, if projected figures for the number of dialysis patients are realised, it risks costing the UK economy approximately £14 billion annually by 2033.[viii] CKD also represents a significant burden on the UK healthcare system, accounting for over 100,000 unplanned hospital admissions in England and Wales every year.[ix]

Fiona Loud, Policy Director at Kidney Care UK, said: “This is a significant development for people with early-stage kidney disease. Slowing down kidney disease can be life-changing, particularly if it reduces the chances of someone needing dialysis or a kidney transplant. The availability of this treatment provides even more incentive for monitoring people most at risk of chronic kidney disease, as it enables diagnosis and appropriate treatment as early as possible.”

Tom Keith-Roach, President, AstraZeneca UK: “We are delighted by NICE’s decision to broaden access to dapagliflozin for patients with CKD. This milestone reflects AstraZeneca’s ongoing commitment to advancing innovative treatments that can make a difference to patient’s lives. CKD places significant burden on patients, their families and our healthcare services and we are proud to play a part in addressing this growing health challenge. We look forward to working in partnership with the health system to ensure eligible patients can benefit from this important therapy as soon as possible.”

CKD is progressive and is often considered a silent disease in its early stages as many patients don’t show symptoms until the disease is already at an advanced stage.[x] People living with CKD have markedly elevated risk of cardiovascular (CV) events, with CV disease being the leading cause of death for this patient population.[xi]^,[xii]

The recommendation from NICE is based on the submission of several data sets, including analysis of RWE (OPTIMISE-CKD), and data from previous clinical studies of dapagliflozin (DAPA-CKD, DAPA-HF and DECLARE-TIMI 58).¹ These data sets provided significant evidence for the benefit of dapagliflozin in patients outside of the eligibility restrictions in eGFR, as outlined in the final appraisal document from NICE in 2022.^1,5

 

– ENDS –

 

CONTACTS

UK Media Enquiries

Georgia Clarke, AstraZeneca: 07586 798507 / georgia.clarke@astrazeneca.com

Lucie Foster, Edelman: 07891 869948 / lucie.foster@edelman.com 

NOTES TO EDITORS

About dapagliflozin
Dapagliflozin is an oral, once-daily selective inhibitor of human sodium-glucose co-transporter 2 (SGLT2).[xiii] Dapagliflozin is indicated in adults for the treatment of chronic kidney disease (CKD).¹³

Common (frequency ≥1/100 to <1/10) adverse events (AEs) associated with dapagliflozin in placebo-controlled clinical studies and post-marketing experience include genital infections; genital fungal infections; urinary tract infection; dizziness; rash; back pain; dysuria; polyuria; haematocrit increased, and creatinine renal clearance decreased during initial treatment and dyslipidaemia.¹³

For complete information on dapagliflozin the summary of product characteristics, including a full list of side effects and adverse reactions is available here:

https://www.medicines.org.uk/emc/product/7607/smpc#gref

About OPTIMISE-CKD

OPTIMISE-CKD was an observational study programme, using claims data sources from the US and Japan, to describe dapagliflozin treatment for CKD in routine clinical practice.[xiv]^,[xv] The study comprised of two components: a descriptive analysis of the real-world utilisation of dapagliflozin 10mg, following its approval for CKD treatment, and an analysis of initiating dapagliflozin 10mg among patients with CKD with urinary albumin-to-creatinine ratio (uACR) <200 mg/g.^14,15 The study demonstrated the efficacy of dapagliflozin in patients with CKD across a range of uACR levels in patients without Type 2 Diabetes Mellitus (T2DM), and in patients with lower uACR levels both with and without T2DM.^14,15

About DAPA-CKD

DAPA-CKD was an international, multi-centre, randomised, double-blinded trial in 4,304 patients, designed to evaluate the efficacy of dapagliflozin 10mg, compared with placebo, in patients with CKD Stages 2-4 and elevated urinary albumin excretion, with and without T2DM.[xvi] Dapagliflozin was given once daily in addition to standard-of-care, which included an angiotensin-converting enzyme inhibitor (ACEi) or an angiotensin receptor blocker (ARB).¹⁶

The primary composite endpoint was worsening of renal function or risk of death (defined as a composite of an eGFR decline ≥50%, onset of end-stage kidney damage (ESKD) or death from CV or renal cause).¹⁶ The secondary endpoints included the time to first occurrence of the renal composite (sustained ≥50% eGFR decline, ESKD or renal death), the composite of CV death or hospitalisation due to heart failure (HF), and death from any cause.¹⁶ Participants with CKD, with or without T2DM, who were randomly assigned to receive dapagliflozin had a lower risk of the primary composite outcome of sustained decline in eGFR of at least 50%, ESKD, or death from renal or cardiovascular causes than participants assigned to receive placebo.¹⁶

About DAPA-HF

DAPA-HF was an international, multi-centre, parallel-group, randomised, double-blinded Phase III trial in 4,744 patients with heart failure with reduced ejection fraction (HFrEF), with and without T2DM.[xvii] The study was designed to evaluate the effect of dapagliflozin 10mg, compared with placebo, given once daily in addition to standard heart-failure device therapy and standard drug therapy, including an angiotensin-converting–enzyme inhibitor, an angiotensin-receptor blocker, or sacubitril–valsartan plus a beta-blocker, unless such use was contraindicated or resulted in unacceptable side effects.¹⁷ Results demonstrated that the risk of the primary composite outcome of worsening heart failure (hospitalisation or an urgent visit resulting in intravenous therapy for heart failure) or death from cardiovascular causes was lower in the dapagliflozin group than in the placebo group.¹⁷ This was observed in those with and without T2DM.¹⁷

About DECLARE-TIMI 58

The DECLARE–TIMI 58 trial was a randomised, double-blind, multinational, placebo-controlled, Phase III trial of dapagliflozin in patients with T2DM, HbA1c 6·5–12·0% (47.5–113.1 mmol/mol), with either established atherosclerotic CV disease or atherosclerotic CV disease risk factors, and creatinine clearance of at least 60 mL/min.[xviii] Patients were randomly assigned (1:1) to 10mg dapagliflozin or placebo once daily.¹⁸ Analysis of a prespecified secondary renal composite outcome (defined as a sustained decline of at least 40% in eGFR to less than 60 mL/min per 1.73m², end-stage renal disease (defined as dialysis for at least 90 days, kidney transplantation, or confirmed sustained eGFR <15mL/min per 1.73m²), or death from renal causes), demonstrated dapagliflozin’s ability to lower the rate of CV death or hospitalisation for heart failure.¹⁸

About CKD
CKD is a serious, progressive condition defined by decreased kidney function (shown by reduced eGFR or markers of kidney damage, or both, for at least three months).[xix] The most common causes of CKD are uncontrolled diabetes and hypertension.⁴ CKD is associated with significant patient morbidity and an increased risk of CV events, such as HF and premature death.[xx]^,[xxi] In its most severe form, known as ESKD, kidney damage and deterioration of kidney function have progressed to the point where dialysis or kidney transplantation are required.[xxii] The majority of patients with CKD will die from CV causes before reaching ESKD.[xxiii]

About AstraZeneca

AstraZeneca 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. AstraZeneca operates in over 100 countries and its medicines are used by millions of patients worldwide.

With a proud 100-year heritage in advancing UK science, today AstraZeneca is the UK’s leading biopharmaceutical company. The company is based in five different locations across the UK, with its global headquarters in Cambridge. In the UK, around 8,700 employees work in research and development, manufacturing, supply, sales, and marketing. We supply around 36 different medicines to the NHS.

For more information, please visit www.astrazeneca.co.uk and follow us on X @AstraZenecaUK.

References

[i] National Institute for Health and Care Excellence. Final Draft Guidance. Dapagliflozin for treating chronic kidney disease. Issue date: 30 May 2025.

[ii] Royal College of Physicians. Time to act: A new review of kidney health inequalities. Available at: https://www.rcp.ac.uk/news-and-media/news-and-opinion/time-to-act-a-new-review-of-kidney-health-inequalities/#:~:text=In%20the%20UK%20more%20than%207.2%20million%20people,factors%20such%20as%20diabetes%2C%20cardiovascular%20disease%20and%20obesity. Last accessed: May 2025.

[iii] Kidney Care UK. One in four people not aware of the main signs of chronic kidney disease. Available at: https://kidneycareuk.org/news-from-kidney-care-uk/one-in-four-people-unaware-of-the-main-signs-of-chronic-kidney-disease/#:~:text=CKD%20currently%20affects%20one%20in%20ten%20people%20%E2%80%93,those%20are%20not%20even%20aware%20they%20have%20CKD. Last accessed: May 2025.

[iv] Kidney Care UK. Key facts about kidneys. Available at: https://kidneycareuk.org/kidney-disease-information/about-kidney-health/facts-about-kidneys/#:~:text=Right%20now%2C%20over%2070%2C000%20people%20in%20the%20UK,fill%20the%20Royal%20Albert%20Hall%20nine%20times%20over%29. Last accessed: May 2025.

[v] National Institute for Health and Care Excellence. Final Draft Guidance. Dapagliflozin for treating chronic kidney disease. Issue date: 3 February 2022.

[vi] Elendu C. et al. Comprehensive review of current management guidelines of chronic kidney disease. Medicine. 2023;102(23):e33984.

[vii] NHS. Overview - Dialysis. Available at: https://www.nhs.uk/conditions/dialysis/. Last accessed: May 2025.

[viii] Kidney Research UK. Kidney disease: A UK public health emergency. Available at: https://www.kidneyresearchuk.org/wp-content/uploads/2023/06/Economics-of-Kidney-Disease-full-report_accessible.pdf. Last accessed: May 2025.

[ix] Healthcare Quality Improvement Partnership. National Chronic Kidney Disease Audit 2017: National Report (Part 2). Available at: https://www.hqip.org.uk/wp-content/uploads/2018/02/national-chronic-kidney-disease-audit-national-report-part-2.pdf. Last accessed: May 2025.

[x] NHS. Symptoms – Chronic Kidney Disease. Available at: https://www.nhs.uk/conditions/kidney-disease/symptoms/. Last accessed: May 2025.

[xi] Zaccali C, et al. Cardiovascular complications in chronic kidney disease: a review from the European Renal and Cardiovascular Medicine Working Group of the European Renal Association. Cardiovascular Research. 2023;119(11):2017-2031.

[xii] Jun M, et al. Managing Cardiovascular Risk in People with Chronic Kidney Disease: A Review of the Evidence from Randomized Controlled Trials. Ther Adv Chronic Dis. 2011;2(4):265-278.

[xiii] Electronic Medicines Compendium. Forxiga 10 mg film-coated tablets. Available at: https://www.medicines.org.uk/emc/product/7607/smpc#gref. Last accessed: May 2025.

[xiv] Svensson MK, et al. Dapagliflozin treatment of patients with chronic kidney disease without diabetes across different albuminuria levels (OPTIMISE-CKD). Clin Kidney J. 2024;17(8):sfae100.

[xv] Tangri N, et al. Dapagliflozin Utilization in Chronic Kidney Disease and Its Real-World Effectiveness Among Patients with Lower Levels of Albuminuria in the USA and Japan. Adv Ther. 2024;41(3):1151-67.

[xvi] Heerspink HJL, et al. Dapagliflozin in patients with chronic kidney disease. N Engl J Med. 2020;383:1436-1446.

[xvii] McMurray JJV, et al. Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction. N Engl J Med. 2019;381:1995-2008.

[xviii] Wiviott SD, et al. Dapagliflozin and Cardiovascular Outcomes in Type 2 Diabetes. N Engl J Med. 2019;380:347-357.

[xix] Renal Association. CKD stages. Available at: https://renal.org/health-professionals/information-resources/uk-eckd-guide/ckd-stages. Last accessed: May 2025.

[xx] NHS. Overview – Chronic kidney disease. Available at: https://www.nhs.uk/conditions/kidney-disease/. Last accessed: May 2025.

[xxi] Jankowski P, et al. Cardiovascular Disease in Chronic Kidney Disease: Pathophysiological Insights and Therapeutic Options. Circulation. 2021;143:1157-1172.

[xxii] White SL, et al. How can we achieve global equity in provision of renal replacement therapy? Bull World Health Organ. 2008;86:229-237.

[xxiii] Briasoulis A, Bakris GL. Chronic kidney disease as a coronary artery disease risk equivalent. Curr Cardiol Rep. 2013;15:340.