AstraZeneca’s Dapagliflozin gets marketing authorisation for chronic kidney disease in India

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.

The receipt of this permission paves way for the launch of Dapagliflozin tablets 10mg into a new disease area to nephrologists 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 chronic kidney disease (CKD).

The study results of dapagliflozin, showed significant benefits in reducing CKD progression in patients with and without type-2 diabetes. The DAPA-CKD study concluded globally on 30th March 2020 based on its effectiveness and safety.

Chronic kidney disease is an emerging public health problem. Global disease burden report of 2015 pointed that CKD is the 12th most common cause of death with a 37.1 per cent rise in mortality over 10 years. It is a serious, progressive condition defined by decreased kidney function and/or kidney damage, affecting nearly 70 Crore people worldwide, many of them still undiagnosed. The prevalence of CKD in India is estimated to be 17.2 per cent, 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.

CKD is associated with significant patient death and an increased risk of cardiovascular (CV) events, such as heart failure and premature death. While there are medications that can address some of the risk factors for CKD or its associated problems, few work directly to slow renal disease progression.

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 (p<0.0001) in patients with chronic kidney disease (CKD) Stages 2-4 and elevated urinary albumin excretion. The results were consistent in patients both with and without type-2 diabetes (T2D).

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 primary composite endpoint was ≥50 per cent 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 per cent 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 per cent (ARR = 2.1 per cent, p=0.0035) compared to placebo.

DAPA-CKD is the first trial to demonstrate efficacy, including improvement on survival, in CKD patients both with and without Type2 Diabetes.

Dr Anil Kukreja, Vice President – Medical Affairs and Regulatory, AstraZeneca India said, “AstraZeneca has always been on the forefront of innovative solution for non-communicable diseases. Despite currently available therapies, a significant unmet need for effective management of CKD continues to exist globally. 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 Chronic Kidney Disease. Dapagliflozin is the first SGLT2 inhibitor to demonstrate such unprecedented efficacy in management of Chronic Kidney disease.”

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. This will go a long way in the effective clinical management of diabetes and its complications in India. 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.”