Bengaluru: Pharmaceutical company AstraZeneca India on Monday announced that it has received marketing authorisation for its anti-diabetic drug dapagliflozin in India for the treatment of patients of chronic kidney disease (CKD) up to third stage.
This permission paves the way for the launch of Dapagliflozin Tablets 10mg into a new disease area in India.
AstraZeneca’s dapagliflozin is the first medicine in SGLT-2i class to move into a new disease area by demonstrating efficacy and safety data for the treatment of patients with CKD, the company said in a statement.
“With the approval of dapagliflozin for CKD in India, an already effective Type-2 Diabetes and select heart failure treatment can now be used by nephrologists in the management of CKD,” said Anil Kukreja, Vice President – Medical Affairs & Regulatory, AstraZeneca India.
“Dapagliflozin is the first SGLT2 inhibitor to demonstrate such unprecedented efficacy in management of Chronic Kidney Disease,” Kukreja added.
Detailed results from the ground-breaking Phase III DAPA-CKD trial showed that AstraZeneca’s 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 per cent compared to placebo 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.
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.
