AstraZeneca India receives marketing permission for QTERN®, once-daily anti-diabetes treatment for adults with type 2 diabetes

QTERN® combines two anti-hyperglycaemic agents with complementary mechanisms of action in a once-daily tablet
 

26 September 2019: AstraZeneca Pharma India Limited (AstraZeneca India) announced that it has received Import & 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.

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 urbanization, industrialization 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.

Gagandeep Singh Bedi, Managing Director, AstraZeneca India said, “Type-2 diabetes is a complex disease that is at epidemic proportions, affecting more than 63 million people in India. 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”

NOTES TO EDITORS

About Type 2 diabetes mellitus

Diabetes mellitus is estimated to affect about 63 million people in India and more than 382 million people worldwide. The prevalence of diabetes is projected to reach more than 592 million people worldwide by 2035. Type 2 diabetes mellitus is a chronic disease characterised by pathophysiologic defects leading to elevated glucose levels. Significant unmet needs still exist, as many patients remain inadequately controlled on their current glucose-lowering regimen. It is estimated that more than half of people living with Type 2 diabetes mellitus are not achieving recommended HbA1c goals based on guidelines established by professional societies and advocacy organisations for diabetes management.

About AstraZeneca

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.

About AstraZeneca Pharma India Limited

AstraZeneca Pharma India Limited (AstraZeneca India) 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

 

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