Astrazeneca Regulatory News (AZN)

This announcement contains inside information

28 February 2017 07:00 GMT

FDA APPROVES ONCE-DAILY QTERN (DAPAGLIFLOZIN AND SAXAGLIPTIN) TABLETS FOR ADULTS WITH TYPE-2 DIABETES

Qtern fixed-dose combination will provide an additional oral medicine option for patients taking Farxiga (dapagliflozin) to improve blood sugar level

AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved once-daily Qtern (10mg dapagliflozin and 5mg saxagliptin) for the treatment of type-2 diabetes. The new medicine is indicated as an adjunct to diet and exercise to improve glycaemic (blood sugar level) control in adults with type-2 diabetes who have inadequate control with dapagliflozin (10mg) or who are already treated with dapagliflozin and saxagliptin.

Elisabeth Björk, Vice President, Head of Cardiovascular and Metabolic Diseases, Global Medicines Development at AstraZeneca, said: "Type-2 diabetes is a complex disease that is at epidemic proportions, affecting more than 29 million people in the US alone. 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." 

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 Farxiga (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.

About Qtern

Qtern combines two anti-hyperglycaemic agents with complementary mechanisms of action in a once-daily tablet: Dapagliflozin, a sodium-glucose cotransporter 2 (SGLT-2) inhibitor; and saxagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor. The FDA approved Qtern based on data from a 24-week, Phase III, multi-centre, randomised, double-blind, placebo-controlled trial (n=315) designed to evaluate the efficacy and safety of saxagliptin added to dapagliflozin in adult patients with type-2 diabetes who experienced inadequate glycaemic control (HbA1c ≥7% to ≤10.5%) with metformin (≥1,500mg per day). The safety of combined use of dapagliflozin and saxagliptin has been evaluated in a pooled safety analysis (N=1,169; 492 treated with Qtern) of three Phase III placebo-controlled clinical trials for up to 52 weeks.

About AstraZeneca in Diabetes

AstraZeneca is pushing the boundaries of science with the goal of developing life-changing medicines that aim to reduce the global burden and complications of diabetes. As a core therapy area for the company, we are focusing our research and development efforts on diverse populations and patients with significant co-morbidities, such as cardiovascular disease, obesity, non-alcoholic steatohepatitis (NASH), and chronic kidney disease.

Our commitment to diabetes is exemplified by the depth and breadth of our global clinical research programme. This commitment is advancing understanding of the treatment effects of our diabetes medicines in broad patient populations, as well as exploring combination product approaches to help more patients achieve treatment success earlier in their disease progression. Our ambition is to reduce the long-term impact of diabetes.

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 main therapy areas - Oncology, Cardiovascular & Metabolic Diseases and Respiratory. The Company also is selectively active in the areas of Autoimmunity, Neuroscience and Infection. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information, please visit www.astrazeneca.com and follow us on Twitter @AstraZeneca.

Adrian Kemp

Company Secretary, AstraZeneca PLC