AstraZeneca gets FDA approval for 'Qternmet XR'

AstraZeneca announced on Friday that the US Food and Drug Administration (FDA) has approved ‘Qternmet XR’ (dapagliflozin, saxagliptin and metformin hydrochloride) extended release tablets as an oral adjunct treatment to diet and exercise, to improve glycaemic control in adults with type-2 diabetes (T2D).

The FTSE 100 pharmaceuticals giant said the approval was based on two phase 3 trials, which evaluated combinations of dapagliflozin and saxagliptin on a background of metformin over 24 weeks, in patients with inadequately-controlled T2D.

It said that in one trial, treatment with 5mg dapagliflozin and 5mg saxagliptin in addition to metformin demonstrated “statistically significant” decreases in HbA1c, which is the average blood glucose level, as well as an increase in the number of patients achieving the recommended HbA1c treatment goal of at least 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 [more than] 7%,” the AstraZeneca board said in its statement.

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