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Farxiga has been approved in the United States for the treatment of chronic kidney disease in patients at risk of progression with or without type 2 diabetes

Approval is the most important advance in the treatment of chronic kidney disease for over 20 years. In a DAPA-CKD phase III trial, Farxiga showed an unprecedented reduction in the combined risk of impaired renal function, end-stage renal disease, cardiovascular or renal death.

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Farxiga (dapagliflozin) from AstraZeneca, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, carries a persistent decrease in estimated glomerular filtration rate (eGFR), end-stage kidney disease (ESKD), and cardiovascular (CV) risk. Approved in the United States to mitigate. ) Death and hospitalization of heart failure (hHF) in adults with chronic kidney disease (CKD) at risk of progression.

Approval by the Food and Drug Administration (FDA) was based on the positive results of the DAPA-CKD Phase III trial.The decision is as follows Priority examination designation Granted by the FDA earlier this year.

CKD, a condition defined by decreased kidney function, is often associated with an increased risk of heart disease and stroke, or the need for dialysis or kidney transplantation. 1-3CKD is expected to be the fifth leading cause of death in the world by 2040.4. It is estimated that 37 million people in the United States have CKD.

Hiddo L, co-chair of the DAPA-CKD trial and its executive committee, the University of Groningen Medical Center in the Netherlands. Professor Heerspink said: SGLT2 inhibitors are approved for the treatment of chronic kidney disease, regardless of diabetic status. This transformational milestone provides patients and physicians with new and effective treatment options for this often debilitating and life-threatening illness. “

Mene Pangalos, Executive Vice President of BioPharmaceuticals R & D, said: It has shown excellent efficacy of Farxiga in type 2 diabetes, low ejection fraction heart failure, and more recently in chronic kidney disease, and we are excited to offer the drug to millions of patients in the United States. “

The DAPA-CKD test shows that Farxiga is an angiotensin converting enzyme inhibitor or Angiotensin receptor blockerReduced relative risk of worsening renal function, developing ESKD, or risk of CV or renal death by 39% at major composite endpoints, compared to placebo, in patients with CKD stages 2-4 and elevated urine Albumin excretion. Absolute risk reduction (ARR) was 5.3% in the median of the 2.4 year study. Farxiga also significantly reduced the relative risk of death from any cause by 31% (ARR = 2.1%, p = 0.0035) compared to placebo.

An exploratory analysis of the DECLARE-TIMI 58 Phase III trial, a randomized, double-blind, placebo-controlled trial conducted to determine the effect of Farxiga on CV results, also showed patients with low-progress Farxiga. It supports the conclusion that it is likely to be valid. CKD. Farxiga is not recommended for the treatment of CKD in patients with polycystic kidney disease, or in patients who require immunosuppressive therapy for renal disease or who have a recent medical history. This is because no effect can be expected in these groups.

In both trials, Farxiga’s safety and tolerability were consistent with the established safety profile of the drug.

In the United States, Farxiga improves glycemic control in adults with type 2 diabetes (T2D) and reduces the risk of hHF in adults with T2D and established CV disease or multiple CV risk factors. Shown as an aid to. Farxiga has also been shown to reduce the risk of CV mortality and hHF in adults with heart failure (NYHA Class II-IV) with reduced ejection fraction (HFrEF) with or without T2D.

Chronic kidney disease

CKD is a severe and progressive condition defined by decreased renal function (indicated by decreased eGFR and / or markers of renal impairment for at least 3 months) 3 and 840 million people worldwide. Affects, many of which have not yet been diagnosed. 6 The most common causes CKD include diabetes, hypertension, and glomerulonephritis 7. CKD is associated with a significant prevalence of patients and an increased risk of CV events such as heart failure (HF) and premature death. In the most severe form, known as ESKD, kidney damage and decreased renal function have progressed to the point where dialysis or kidney transplantation is required1. The majority of patients with CKD die from CV before reaching ESKD8.

DAPA-CKD

DAPA-CKD was an international, multicenter, randomized, double-blind, phase III study of 4,304 patients designed to be evaluated. Effectiveness of Farxiga 10 mg compared to placebo was used in patients with increased urinary albumin excretion at CKD stages 2-4, with or without T2D. Farxiga was given once daily in addition to standard treatment. The primary composite endpoint was aggravation of renal function or risk of death (defined as a composite of> 50% reduction in eGFR, onset of EGFR, or death from CV or renal cause). Secondary endpoints include time to first onset of renal complex (≥50% reduction in eGFR, persistence of ESKD or renal death), CV death or hHF complex, and death from any cause. Was there. The test was conducted in 21 countries. 9 Detailed results of the test New England Journal of Medicine.9

Declaration-TIMI58

DECLARE-TIMI 58 is AstraZeneca-sponsored randomization designed to assess the effect of Farxiga compared to placebo on CV outcomes in adults with T2D at risk for CV events, including multiple CV patients. It was a double-blind, multicenter, phase III trial. We also evaluated risk factors or established CV disease, as well as major renal exploration endpoints. The study enrolled more than 17,000 patients at 882 sites in 33 countries and was conducted independently in collaboration with academic researchers from the TIMI research group (Boston, USA) and the Hebrew University of Jadasa Medical Center (Jerusalem, Israel). it was done. The result of the test is Lancet.Ten

Falxiga

Farxiga (dapagliflozin) is the first oral, once-daily SGLT2 inhibitor in its class. Farxiga’s work is moving from cardiorenal effects to prevention and organ protection as science continues to identify the underlying association between the heart, kidneys, and pancreas. If one of these organs is damaged, the other organs can fail. It is one of the leading causes of death worldwide, including type 2 diabetes, HF and CKD.

For almost a decade, Farxiga has been an effective monotherapy and has been part of a combination of diet and exercise aids to improve glycemic control in adults with T2D. Following the results of a breakthrough DECLARE-TIMI 58 Phase III CV outcome trial, it has been approved in adults with T2D to reduce the risk of death from hHF or CV when added to standard treatment11. First approved SGLT2 inhibitor For the treatment of HFrEF in adults with or without T2D.

August 2020, Results of DAPA-CKD Phase III study Farxiga demonstrated that the combined risk of renal failure and CV or renal death in patients with CKD with or without T2D was unprecedentedly reduced compared to placebo9. Provides patient population and organ protection.

DapaCare is a powerful clinical trial program to assess the potential CV, kidney and organ protection benefits of Farxiga. This includes more than 35 completed and ongoing Phase IIb / III trials in more than 35,000 patients and more than 2.5 million patient years of experience. It is currently being evaluated in the DELIVER Phase III trial in HF patients with diastolic dysfunction. Farxiga is a DAPA-MI phase III trial (the first registry-based randomized controlled trial to seek indications) and is also being tested in patients without acute myocardial infarction (MI) or type 2 diabetes after a heart attack. ..

CVRM AstraZeneca

Cardiovascular, kidney and metabolism (CVRM), which are part of BioPharmaceuticals, are one of AstraZeneca’s three therapeutic areas and are our key growth drivers. AstraZeneca invests in a portfolio of medicines for organ protection by following science to better understand the underlying associations of the heart, kidneys and pancreas, slowing disease progression, reducing risk and comorbidities. We are improving the outcome by working on. Our goal is to correct or stop the natural course of CVRM disease and regenerate organs by continuing to provide treatments and innovative science to improve cardiovascular health to millions of patients worldwide. To restore functionality.

AstraZeneca

AstraZeneca (LSE / STO / Nasdaq: AZN) is a science focused on the discovery, development, and commercialization of prescription drugs in oncology and biopharmacy, including cardiovascular, renal and metabolic, respiratory and immunology. A leading global biopharmacy company. Based in Cambridge, UK, AstraZeneca operates in more than 100 countries and its innovative medicines are used by millions of patients worldwide.Please come astrazeneca.com Follow the company on Twitter @AstraZeneca..

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References

1. Centers for Disease Control and Prevention (CDC). Chronic kidney disease in the United States, 2019. [cited 2021 Apr 29].. Available locations: 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 Integrated 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 of the 2017 Global Disease Burden Study. The lancet. 2020; 395 (10225): 709-733.

4. Foreman KJ, etc. Life expectancy of 250 causes of death, years lost, and mortality projections specific to all causes and causes: 2016-40 reference and alternative scenarios for 195 countries and territories. The lancet. 2018; 392 (10159): 2052-2090.

5. Heerspink H.DAPA-CKD-Dapagliflozin in patients with chronic kidney disease. Announcement location: ESC Congress 2020-The Digital Experience, August 29-September 1, 2020.

6. Jager KJ, et al. A single number of advocacy and communication — more than 850 million individuals worldwide suffer from kidney disease. Neflor dial transplant. 2019; 34 (11): 1803-1805.

7. National Kidney Foundation.Kidney disease: Cause; 2015 [cited 2021 Apr 29].. Available locations: URL: https://www.kidney.org/atoz/content/kidneydiscauses..

8. Briasoulis A, Bakris GL. Chronic kidney disease as a coronary artery disease carries the same risk. Curr Cardiol Rep.2013; 15 (3): 340.

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

10. Mosenzon O, et al.Effects of dapagliflozin on the onset and progression of renal disease Patients with type 2 diabetes: DECLARE–TIMI58 Analysis from randomized trials. The lancet. 2019; 7 (8): 606-617.

11. DECLARE-TIMI 58 Investigators Wiviott SD and others. Dapagliflozin and cardiovascular outcomes in type 2 diabetes [article and supplementary appendix].. N Engl J Med. 2019: 380: 347-357.



Farxiga has been approved in the United States for the treatment of chronic kidney disease in patients at risk of progression with or without type 2 diabetes

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