AstraZeneca India, a leading science-led biopharmaceutical company announced on Thursday 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 its class to show 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. 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.
DAPA-CKD is the first trial to demonstrate efficacy, including improvement on survival, in CKD patients both with and without Type2 Diabetes.