AstraZeneca to launch once-daily anti-diabetes drug in India
AstraZeneca Pharma announced it has received import and market permission 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, says a company statement.
QTERN is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus. 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, it adds.
Gagandeep Singh Bedi, MD AstraZeneca India said, "The approval of QTERN is good news for patients who may benefit from improved glycaemic control by adding a DPP-4 inhibitor to a SGLT-2 inhibitor in a convenient once-daily tablet.”