FDA Approves Novel Diabetes Drug

Today, the FDA approved once-daily Qtern (10-mg dapagliflozin and 5-mg saxagliptin) to treat type 2 diabetes. The fixed-dose combination drug will provide another oral treatment option for patients with diabetes.

Qtern is indicated to improve blood sugar control when used with diet and exercise in adults whose diabetes is inadequately controlled with dapagliflozin, or who were previously treated with dapagliflozin and saxagliptin, AstraZeneca reported.

Dapagliflozin is a sodium-glucose cotransporter 2 (SGLT-2) inhibitor, and saxagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor. SGLT-2 inhibitors improve glycemic control by reducing absorption of glucose in the blood, and have been observed to reduce HbA1c, weight, and blood pressure. DPP-4 inhibitors also reduce blood glucose levels.

The new approval was based on positive data from a 24-week clinical trial designed to assess the safety and efficacy of the combination treatment in 315 patients with type 2 diabetes who experienced inadequate glycemic control with metformin, according to the press release.

Qtern was evaluated in nearly 500 patients over multiple phase 3 clinical trials for up to 52 weeks, and demonstrated glucose-lowering properties.

The drug was previously approved in the European Union in July 2016 for the treatment of patients with type 2 diabetes who did not achieve glucose control on metformin, sulphonyluera, or with dapagliflozin or saxagliptin monotherapy. Qtern was the first SGLT-2/DPP-4 inhibitor combination drug to be approved in Europe, according to AstraZeneca.

“Type-2 diabetes is a complex disease that is at epidemic proportions, affecting more than 29 million people in the US alone,” said Elisabeth Björk, vice president, head of Cardiovascular and Metabolic Diseases, Global Medicines Development at AstraZeneca. “The approval of Qtern is good news for patients who may benefit from improved glycaemic [sic] control by adding a DPP-4 inhibitor to a SGLT-2 inhibitor in a convenient once-daily tablet.”