The receipt of the permission paves way for the launch of dapagliflozin tablets (10 mg) in the country to treat CKD, the company said in a statement.
The drug 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, it added.
The study results of dapagliflozin showed significant benefits in reducing CKD progression in patients with and without type-2 diabetes.
"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 CKD," AstraZeneca India Vice President - Medical Affairs and Regulatory Anil Kukreja said.
CKD is an emerging public health problem. The 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 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 1 billion plus population, 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.
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