MISSISSAUGA, ON, August 10, 2021 – AstraZeneca Canada announced today that Health Canada has approved Forxiga® (dapagliflozin), a sodium-glucose cotransporter 2 (SGLT2) inhibitor, to reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline, end-stage kidney disease (ESKD), and cardiovascular (CV) and renal death in adults with chronic kidney disease (CKD).
The approval was based on positive results from the DAPA-CKD Phase III trial and follows the Priority Review designation granted by Health Canada in December of 2020.
“With the completion of DAPA-CKD, we have witnessed that across the spectrum of patients in the trial, including those with chronic kidney disease stage 4, dapagliflozin showed cardiorenal benefit in both those with and without type-2 diabetes,” said Dr. David Cherney, Nephrologist in Toronto and Canadian lead investigator for DAPA-CKD trial. “This approval is an exciting advance for people with chronic kidney disease, providing patients and physicians with a new and effective treatment that has the potential to help reduce the risk of kidney function decline, end-stage kidney disease, and mortality.”
CKD, a condition defined by decreased kidney function, is often associated with a heightened risk of heart disease or stroke, or the need for dialysis or kidney transplant.1-3 CKD is expected to become the fifth leading cause of mortality globally by 2040.4 Currently in Canada, four million people are estimated to have CKD.5
“Chronic kidney disease is a debilitating and life-threatening disease that is vastly underdiagnosed," said Elizabeth Myles, National Executive Director of The Kidney Foundation of Canada. "It's encouraging that new treatment options are being approved for patients with chronic kidney disease – with and without type-2 diabetes.”
“Today’s approval is an important advancement in the treatment of chronic kidney disease.” said Dr. Alex Romanovschi, Vice President, Scientific Affairs, AstraZeneca Canada. “Forxiga is already approved for the treatment of type-2 diabetes and heart failure with reduced ejection fraction, and we are excited to now be able to bring this medicine to millions of Canadian patients with chronic kidney disease.”
The DAPA-CKD trial demonstrated that Forxiga, on top of standard-of-care treatment with an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker, reduced the relative risk of worsening of renal function, onset of ESKD, or risk of CV or renal death by 39%, the primary composite endpoint, compared to placebo (p<0.0001) in patients with CKD Stages 2-4 and elevated urinary albumin excretion. The absolute risk reduction (ARR) was 5.3% over the median time in study of 2.4 years.
In Canada, Forxiga is indicated as an adjunct to diet and exercise to improve glycemic control in adult patients with type-2 diabetes (T2D) for whom metformin is inappropriate due to contraindications or intolerance, or when existing therapies, along with diet and exercise, do not provide adequate glycemic control. Forxiga is also indicated as an adjunct to diet, exercise, and standard of care therapy to reduce the risk of hHF in adults with T2D and established CV disease or multiple CV risk factors. Forxiga is also indicated in adults, as an adjunct to standard of care therapy, for the treatment of heart failure with reduced ejection fraction (HFrEF) to reduce the risk of CV death, hHF, and urgent HF visit.
Forxiga (dapagliflozin) is a first-in-class, oral, once-daily SGLT2 inhibitor. The research for Forxiga is advancing from cardiorenal effects to prevention and organ protection as science continues to identify the underlying links between the heart, kidneys, and pancreas. 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.6-9
DapaCare is a robust program of clinical trials to evaluate the potential CV, renal and organ protection benefits of Forxiga. It 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.
About Chronic Kidney Disease
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) and/or kidney damage3 affecting 840 million people worldwide, including four million Canadians.5 The most common causes of CKD are diabetes, hypertension, and glomerulonephritis.10 CKD is associated with significant patient morbidity and an increased risk of CV events, such as heart failure (HF) and premature death. In its most severe form, known as ESKD, kidney damage and deterioration of kidney function have progressed to the stage where dialysis or kidney transplantation are required.1 The majority of patients with CKD will die from CV causes before reaching ESKD.11
About AstraZeneca Canada
AstraZeneca is a global, innovation-driven biopharmaceutical business with a focus on the discovery, development and commercialization of primary and specialty care medicines that transform lives. Our primary focus is on four important areas of healthcare: Cardiovascular, Renal and Metabolic disease; Oncology; Respiratory & Immunology; and Rare Diseases. AstraZeneca operates in more than 100 countries and its innovative medicines are used by millions of patients worldwide. In Canada, we employ roughly 1,050 employees across the country and our headquarters are located in Mississauga, Ontario. For more information, please visit the company’s website at www.astrazeneca.ca.
1. Centers for Disease Control and Prevention (CDC). Chronic kidney disease in the United States, 2019. [cited 2021 Apr 29]. Available from: URL: https://www.cdc.gov/kidneydisease/publications-resources/2019-national-facts.html.
2. Segall L, et al. Heart failure in patients with chronic kidney disease: a systematic integrative review. Biomed Res Int. 2014;2014:937398.
3. Bikbov B, et al. Global, regional, and national burden of chronic kidney disease, 1990–2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2020;395(10225):709-733.
4. Foreman KJ, et al. Forecasting life expectancy, years of life lost, and all-cause and cause-specific mortality for 250 causes of death: reference and alternative scenarios for 2016-40 for 195 countries and territories. Lancet. 2018;392(10159):2052-2090.
5. Kidney Foundation, Facing the Facts, 2020. https://kidney.ca/KFOC/media/images/PDFs/Facing-the-Facts-2020.pdf. Accessed August 2021.
6. Houlden RL. Can J Diabetes 42 2018; S1–S5.
7. Bello AK et al. Kidney Int Rep 2019; 4:561–570.
8. Suckling R et al. J Ren Care 2012;38(Suppl 1):4–11.
9. Fox CS et al. Lancet. 2012; 380: 1662–73. IDF Atlas, 2017.
10. National Kidney Foundation. Kidney Disease: Causes; 2015 [cited 2021 Apr 29]. Available from: URL: https://www.kidney.org/atoz/content/kidneydiscauses.
11. Briasoulis A, Bakris GL. Chronic kidney disease as a coronary artery disease risk equivalent. Curr Cardiol Rep. 2013;15(3):340.