DCGI approves dapagliflozin for chronic kidney disease in IndiaFebruary 9, 2021
AstraZeneca India has received marketing authorisation for their anti-diabetic drug dapagliflozin, in India for the treatment of patients of chronic kidney disease (CKD) up to stage III.
Dapagliflozin is a glucose-lowering sodium/glucose cotransporter-2 inhibitor (SGLT2i) drug. The study results of dapagliflozin, showed significant benefits in reducing CKD progression in patients with and without type-2 diabetes, according to the company.
The results from the phase III DAPA-CKD trial showed that dapagliflozin on top of standard of care reduced the composite measure of worsening of renal function or risk of cardiovascular (CV) or renal death by 39% compared to placebo (p<0.0001) in patients with CKD stages 2-4 and elevated urinary albumin excretion. The results were consistent in patients both with and without type-2 diabetes (T2D).
The primary composite endpoint was ≥50% sustained decline in estimated glomerular filtration rate (eGFR), onset of end-stage kidney disease (ESKD) and CV or renal death. The absolute risk reduction (ARR) was 5.3% over the median time in study of 2.4 years. The trial also met all secondary endpoints, including significantly reducing death from any cause by 31% (ARR = 2.1%, p=0.0035) compared to placebo.
Dr Dinesh Khullar, National lead investigator of Dapa-CKD in India, said “Dapagliflozin, a SGLT2 inhibitor, has provided enough research-based evidence to show its efficacy in the management of Type 2 diabetes and select heart failure patients. It can now be safely used to delay the progression of chronic kidney disease both in diabetics and non diabetics. Its approval by the regulatory bodies in India is a welcome move and will benefit CKD patients, both diabetics and non diabetics, including those where the disease has already progressed significantly.”
In July 2020, Dapagliflozin was approved by USFDA as well as in India to reduce the risk of CV death and hospitalisation for heart failure (hHF) in adults with heart failure (NYHA class II-IV) with reduced ejection fraction (HFrEF) with and without T2D.
Dapagliflozin is currently being assessed in patients with heart failure (HF) in the DELIVER (HF with preserved ejection fraction, HFpEF) and DETERMINE (HFrEF and HFpEF) trials, as well as in patients without T2D following an acute myocardial infarction (MI) or heart attack in the DAPA-MI trial.
CKD is a serious, progressive condition defined by decreased kidney function affecting nearly 700 million people worldwide, many of them still undiagnosed, and the most common causes are diabetes, hypertension and glomerulonephritis. The prevalence of CKD in India is estimated to be 17.2%, given its population >1 billion, the rising incidence of CKD is likely to pose major problems for both healthcare and the economy in future years.