Combination Drug for Adults with T2D is Granted FDA Approval

Officials with the FDA have approved AstraZeneca’s dapagliflozin, saxagliptin and metformin hydrochloride (Qternmet XR) extended release tablets as an oral adjunct treatment to diet and exercise to improve glycaemic control in adults with type-2 diabetes (T2D), according to the company.

The combination drug is a once-daily, oral medicine. Dapagliflozin is a selective sodium‑glucose cotransporter-2 (SGLT-2) inhibitor that is combined with a dipeptidyl peptidase‑4 (DPP‑4) inhibitor, saxagliptin; and metformin hydrochloride extended release.

The approval is based on 2 Phase III trials that evaluated combinations of dapagliflozin and saxagliptin on a background of metformin over 24 weeks, in patients with inadequately-controlled T2D, said AstraZeneca officials, in a press release.

In the first trial, treatment with 5mg dapagliflozin/5mg saxagliptin in addition to metformin demonstrated statistically-significant decreases in HbA1c (average blood glucose levels), and an increase in the number of patients achieving the recommended HbA1c treatment goal of <7%.

In the second trial, treatment with 10mg dapagliflozin/5mg saxagliptin in addition to metformin extended release demonstrated statistically-significant decreases in HbA1c, and an increase in the number of patients achieving an HbA1c <7%.

The safety results of the individual medicines in these trials were consistent with their known profile.

Reference

Qternmet XR approved in the US for the treatment of type-2 diabetes [news release]. Cambridge, United Kingdom; May 3, 2019: AstraZeneca. https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2019/qternmet-xr-approved-in-the-us-for-the-treatment-of-type-2-diabetes-03052019.html. Accessed May 6, 2019.