AstraZeneca’s Dapagliflozin receives Marketing Authorisation for Chronic Kidney Disease in India

·       AstraZeneca’s dapagliflozin receives marketing authorisation based on global clinical study conducted in India and other parts of the world.

·       The clinical study results had shown that dapagliflozin positively reduced chronic kidney disease (CKD) progression in patients with or without type 2 diabetes

 

Bangalore, India: AstraZeneca India (AstraZeneca Pharma India Limited), a leading science-led biopharmaceutical company, today announced that they have 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% 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%, 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% 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% 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.

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 & 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.” 

In July 2020Dapagliflozin 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 – a first of its kind, indication-seeking registry-based randomised controlled trial.

 

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Chronic Kidney Disease

CKD can be 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). The most common causes of CKD are diabetes, hypertension and glomerulonephritis. CKD is associated with significant patient morbidity and an increased risk of CV events, such as 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. The majority of patients with CKD will die from CV causes before reaching ESKD.

 

About AstraZeneca Pharma India Limited

 

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, Cardiovascular, Renal & Metabolism and Respiratory. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.

AstraZeneca Pharma India Limited (AZPIL) was established in 1979 and is marking its 40th year of long-standing commitment to patients in India. It is headquartered at Bengaluru, Karnataka. AstraZeneca India has a workforce of over 1400 employees across the country committed to deliver great medicines to patients through innovative science and global excellence in development and commercialization. For more information, please visit: www.astrazeneca.com/india

 

Media Contact:

Chandrashekar Deshpande | Email: chandrashekhar.deshpande@astrazeneca.com