AstraZeneca Pharma has received import and market permission in Form 45 (marketing authorization) for QTERN (fixed dose combination of dapagliflozin 10mg + saxagliptin 5mg) in India by the Drug Controller General of India (DCGI). This permission paves way for the launch of QTERN in India, subject to the receipt of further related statutory approvals and licenses.
QTERN is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type-2 diabetes mellitus (T2DM). QTERN combines two anti-hyperglycaemic agents with complementary mechanisms of action in a once-daily tablet. The drug comprises sodium-glucose cotransporter 2 (SGLT2) inhibitor- dapagliflozin and a dipeptidyl peptidase-4 (DPP-4) inhibitor saxagliptin.
SGLT-2 inhibitors help patients achieve improved glycaemic control by reducing the reabsorption of glucose from the blood and enabling its removal via the urine. SGLT-2 inhibitors, including Forxiga (dapagliflozin), have demonstrated reductions in HbA1c and have also been shown to reduce weight and blood pressure. DPP-4 inhibitors reduce blood glucose as measured by HbA1c.
Type-2 diabetes in India is a disease of epidemic scale affecting over 63 million people. Rapid urbanisation, industrialisation and demographic transition resulting in altered lifestyles have been identified as the main causes for this alarming number. Significant unmet needs still exist, as many patients remain inadequately controlled on their current glucose-lowering regimen. QTERN will provide yet another option to physicians to help them in managing type 2 diabetes of their patients.